{
  "format": "devicerts.device.v1",
  "cite_as": "Rapid DeltaFuse, iSchemaView, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/rapid-deltafuse-llz (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/rapid-deltafuse-llz",
    "json_url": "https://devicerts.com/devices/rapid-deltafuse-llz.json",
    "markdown_url": "https://devicerts.com/devices/rapid-deltafuse-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/rapid-deltafuse-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": "Rapid DeltaFuse",
    "registry_name": "Rapid DeltaFuse",
    "url": "https://devicerts.com/devices/rapid-deltafuse-llz",
    "manufacturer": {
      "name": "iSchemaView, Inc.",
      "url": "https://devicerts.com/manufacturers/ischemaview-inc",
      "country": "United States",
      "country_basis": null,
      "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": "K252526",
            "registries": [
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            ]
          }
        ]
      }
    ],
    "product_codes": [
      "LLZ"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Rapid DeltaFuse is an image processing system intended for radiological applications. It processes and analyzes medical images to assist clinicians in diagnostic decision‑making.\n\nThe device was cleared through an FDA 510(k) submission (K252526) and is classified as a Class II system, image processing, radiological device (product code LLZ). It is submitted by Ischemaview, Inc. of Golden, Colorado, and marketed by iSchemaView, Inc.",
      "ai_generated": true,
      "generated_on": "2026-09-24",
      "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": "K252526",
      "number_label": null,
      "device_udi_di": null,
      "date": "2025-08-26",
      "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",
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        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K252526",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "LLZ",
              "registries": [
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            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
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        {
          "label": "Device class",
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              "value": "Class II",
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            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 892.2050",
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            }
          ]
        },
        {
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    }
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}