{
  "format": "devicerts.device.v1",
  "cite_as": "Surgical Navigation Advanced Platform (SNAP), Surgical Theater LLC. deviCERTS medical device catalogue. https://devicerts.com/devices/surgical-navigation-advanced-platform-snap-llz (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/surgical-navigation-advanced-platform-snap-llz",
    "json_url": "https://devicerts.com/devices/surgical-navigation-advanced-platform-snap-llz.json",
    "markdown_url": "https://devicerts.com/devices/surgical-navigation-advanced-platform-snap-llz.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "registry_records_last_synced": "2026-10-22",
    "status_as_of": "2026-11-15",
    "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/surgical-navigation-advanced-platform-snap-llz",
    "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": "Surgical Navigation Advanced Platform (SNAP)",
    "registry_name": "Surgical Navigation Advanced Platform (SNAP)",
    "url": "https://devicerts.com/devices/surgical-navigation-advanced-platform-snap-llz",
    "manufacturer": {
      "name": "Surgical Theater LLC",
      "url": "https://devicerts.com/manufacturers/surgical-theater-llc",
      "country": "United States",
      "country_basis": "FDA 510(k) applicant",
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K160584",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "LLZ"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Surgical Navigation Advanced Platform (SNAP) is a software interface and image segmentation system used to transfer imaging information from medical scanners such as CT, MR or X-ray 3D Angiography (XA) to an output file. It is also used for simulating surgical treatment options pre-operatively and post-operatively.\n\nThe SNAP system features a compact and sturdy design with a slim cart suitable for operating rooms and an iPad for displaying the main screen image, allowing for full control capabilities and remote use. It is supplied with an iPad and is intended for use in operating rooms. The device has been cleared by the FDA with a 510(k) clearance (K160584).",
      "ai_generated": true,
      "generated_on": "2026-10-06",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K160584",
      "number_label": null,
      "device_udi_di": null,
      "date": "2016-06-28",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [
    {
      "number": "Z-0322-2026",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2025-09-16",
      "reason": "A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.",
      "applies": "this device",
      "via": "K160584"
    },
    {
      "number": "Z-0320-2026",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2025-09-16",
      "reason": "A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.",
      "applies": "this device",
      "via": "K160584"
    },
    {
      "number": "Z-0321-2026",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2025-09-16",
      "reason": "A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.",
      "applies": "this device",
      "via": "K160584"
    },
    {
      "number": "Z-0323-2026",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2025-09-16",
      "reason": "A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.",
      "applies": "this device",
      "via": "K160584"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K160584",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "LLZ",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 892.2050",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Radiology",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA decision",
          "values": [
            {
              "value": "SESE",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    }
  ]
}