{
  "format": "devicerts.device.v1",
  "cite_as": "9l-Rs, GE Healthcare Japan Corporation. deviCERTS medical device catalogue. https://devicerts.com/devices/9l-rs-h40442ll (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/9l-rs-h40442ll",
    "json_url": "https://devicerts.com/devices/9l-rs-h40442ll.json",
    "markdown_url": "https://devicerts.com/devices/9l-rs-h40442ll.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      },
      {
        "registry": "FDA GUDID (AccessGUDID)",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "registry_records_last_synced": "2026-10-22",
    "status_as_of": "2026-11-14",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/devices/9l-rs-h40442ll",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "device": {
    "name": "9l-Rs",
    "registry_name": "9L-RS",
    "url": "https://devicerts.com/devices/9l-rs-h40442ll",
    "manufacturer": {
      "name": "GE Healthcare Japan Corporation",
      "url": "https://devicerts.com/manufacturers/fda-fei-3002808529",
      "country": "Japan",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "European Union and United States"
    },
    "classification": [
      {
        "class": "Class IIa",
        "system": "EU MDR"
      },
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "Primary DI / UDI-DI",
        "values": [
          {
            "value": "00840682110006",
            "registries": [
              "EUDAMED",
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      },
      {
        "label": "Basic UDI-DI",
        "values": [
          {
            "value": "8406821BUG00232H3",
            "registries": [
              "EUDAMED"
            ]
          }
        ]
      },
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K160184",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "IYN",
      "ITX",
      "IYO"
    ],
    "emdn": [
      {
        "code": "Z110402010101",
        "term": "TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES"
      }
    ],
    "gmdn": [
      {
        "code": "40768",
        "term": "Extracorporeal ultrasound imaging transducer, hand-held"
      }
    ],
    "description": null,
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "EUDAMED",
      "region": "European Union",
      "type": "CE/MDR",
      "number": "8406821BUG00232H3",
      "number_label": "Basic UDI-DI",
      "device_udi_di": "00840682110006",
      "date": "2026-04-25",
      "date_kind": "registered",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    },
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "GUDID listing",
      "number": "00840682110006",
      "number_label": "UDI-DI",
      "device_udi_di": null,
      "date": "2016-07-15",
      "date_kind": "listed",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Listed",
      "status_note": "GUDID: in commercial distribution",
      "derived_from_gudid": false
    },
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K160184",
      "number_label": null,
      "device_udi_di": null,
      "date": "2016-02-25",
      "date_kind": "issued",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": true
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [
    {
      "number": "Z-0865-2024",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2023-12-22",
      "reason": "GE HealthCare has become aware of an issue with certain IC9-RS ultrasound probes (see Affected Products List) that can result in a double image artifact creating a ghost image with realistic features. An unrecognized artifact may lead to misdiagnosis.",
      "applies": "this device",
      "via": "K160184"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identity",
      "fields": [
        {
          "label": "Generic name",
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            {
              "value": "Extracorporeal ultrasound imaging transducer, hand-held",
              "registries": [
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              ]
            }
          ]
        },
        {
          "label": "Model / reference",
          "values": [
            {
              "value": "5212630",
              "registries": [
                "EUDAMED"
              ]
            },
            {
              "value": "H40442LL",
              "registries": [
                "EUDAMED"
              ]
            },
            {
              "value": "9L-RS",
              "registries": [
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              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Identifiers",
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          "label": "Primary DI / UDI-DI",
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          ]
        },
        {
          "label": "Basic UDI-DI",
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            {
              "value": "8406821BUG00232H3",
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                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Direct marketing DI",
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            {
              "value": "00840682110006",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "510(k) Number",
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              "value": "K160184",
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            }
          ]
        },
        {
          "label": "FDA product code",
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            {
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            },
            {
              "value": "IYO",
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          ]
        },
        {
          "label": "EMDN code",
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            {
              "value": "Z110402010101",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "GMDN term",
          "values": [
            {
              "value": "Extracorporeal ultrasound imaging transducer, hand-held",
              "code": "40768",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
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        {
          "label": "Device class",
          "values": [
            {
              "value": "Class IIa",
              "registries": [
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            },
            {
              "value": "Class II",
              "registries": [
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        },
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            {
              "value": "892.1570",
              "registries": [
                "FDA GUDID (AccessGUDID)"
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            {
              "value": "892.1560",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
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        {
          "label": "EU registration type",
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            {
              "value": "Standard device",
              "registries": [
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              ]
            }
          ]
        },
        {
          "label": "EU market of registration",
          "values": [
            {
              "value": "France",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "GUDID distribution status",
          "values": [
            {
              "value": "In Commercial Distribution",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Properties",
      "fields": [
        {
          "label": "Prescription use",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Serial number",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Manufacturing date",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Supplied sterile",
          "values": [
            {
              "value": "No",
              "registries": [
                "EUDAMED",
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Sterilise before use",
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              "registries": [
                "EUDAMED",
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Single use",
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              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
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            }
          ]
        },
        {
          "label": "Implantable",
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              "registries": [
                "EUDAMED",
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Reusable",
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            {
              "value": "No",
              "registries": [
                "EUDAMED"
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            }
          ]
        },
        {
          "label": "Contains latex",
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            {
              "value": "No",
              "registries": [
                "EUDAMED",
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Reprocessed single-use device",
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              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)",
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              "registries": [
                "EUDAMED"
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          ]
        },
        {
          "label": "Incorporates a substance derived from human blood or plasma",
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              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Contains human tissues or cells",
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              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Contains animal tissues or cells",
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            {
              "value": "No",
              "registries": [
                "EUDAMED"
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            }
          ]
        },
        {
          "label": "Contains endocrine-disrupting substances",
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            {
              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Administering medicine",
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              "value": "No",
              "registries": [
                "EUDAMED"
              ]
            }
          ]
        },
        {
          "label": "Measuring function",
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                "EUDAMED"
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            }
          ]
        },
        {
          "label": "Incorporates a medicinal substance",
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              "registries": [
                "EUDAMED"
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            }
          ]
        },
        {
          "label": "Over-the-counter",
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        {
          "label": "Convenience kit",
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              "registries": [
                "FDA GUDID (AccessGUDID)"
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          ]
        },
        {
          "label": "Combination product",
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              "registries": [
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            }
          ]
        },
        {
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              "registries": [
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            }
          ]
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        {
          "label": "Premarket exempt",
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              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Lot / batch number",
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              "registries": [
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              ]
            }
          ]
        },
        {
          "label": "Expiration date",
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              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        }
      ]
    }
  ]
}