{
  "format": "devicerts.device.v1",
  "cite_as": "TECHFIT Diagnostic Models, Techfit Digital Surgery, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/techfit-diagnostic-models-llz (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/techfit-diagnostic-models-llz",
    "json_url": "https://devicerts.com/devices/techfit-diagnostic-models-llz.json",
    "markdown_url": "https://devicerts.com/devices/techfit-diagnostic-models-llz.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "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/techfit-diagnostic-models-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": "TECHFIT Diagnostic Models",
    "registry_name": "TECHFIT Diagnostic Models",
    "url": "https://devicerts.com/devices/techfit-diagnostic-models-llz",
    "manufacturer": {
      "name": "Techfit Digital Surgery, Inc.",
      "url": "https://devicerts.com/manufacturers/techfit-digital-surgery-inc",
      "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": "K222577",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "LLZ"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "TECHFIT Diagnostic Models are medical devices used for diagnostic purposes in radiology applications. These models are designed to assist in medical imaging procedures and diagnostic assessments.\n\nThe TECHFIT Diagnostic Models are supplied by Techfit Digital Surgery, Inc. and have received FDA 510K clearance with K number K222577. The devices are regulated under product code LLZ and were cleared as substantially equivalent on January 6, 2023.",
      "ai_generated": true,
      "generated_on": "2026-09-23",
      "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": "K222577",
      "number_label": null,
      "device_udi_di": null,
      "date": "2023-01-06",
      "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": [],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K222577",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "LLZ",
              "registries": [
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              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
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            {
              "value": "Class II",
              "registries": [
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              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 892.2050",
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            }
          ]
        },
        {
          "label": "Advisory committee",
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              "value": "Radiology",
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            {
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        }
      ]
    }
  ]
}