{
  "format": "devicerts.device.v1",
  "cite_as": "Autospect, Philips Medical Systems (Cleveland), Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/autospect-kps (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/autospect-kps",
    "json_url": "https://devicerts.com/devices/autospect-kps.json",
    "markdown_url": "https://devicerts.com/devices/autospect-kps.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/"
      }
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    "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/autospect-kps",
    "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": "Autospect",
    "registry_name": "AUTOSPECT",
    "url": "https://devicerts.com/devices/autospect-kps",
    "manufacturer": {
      "name": "Philips Medical Systems (Cleveland), Inc.",
      "url": "https://devicerts.com/manufacturers/philips-medical-systems-cleveland-inc",
      "country": "United States",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
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      "label": "Active",
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    },
    "classification": [
      {
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          {
            "value": "K090403",
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              "FDA 510(k)"
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        ]
      }
    ],
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      "KPS"
    ],
    "emdn": [],
    "gmdn": [],
    "description": null,
    "noindex": false
  },
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    {
      "registry": "510(k)",
      "region": "United States",
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      "number": "K090403",
      "number_label": null,
      "device_udi_di": null,
      "date": "2009-03-31",
      "date_kind": "decision",
      "decision_code": "SESE",
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      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
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  "certificates": [],
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    {
      "number": "Z-1504-2016",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2016-03-04",
      "reason": "The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90 or 180 relative to one another.  However, certain gamma cameras allow for other relative detector angles.  Data acquired at these other angles will not be correctly reconstructed by AutoSPECT Pro and the results will likely be erroneous.",
      "applies": "this device",
      "via": "K090403"
    },
    {
      "number": "Z-1505-2016",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2016-03-04",
      "reason": "The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90 or 180 relative to one another.  However, certain gamma cameras allow for other relative detector angles.  Data acquired at these other angles will not be correctly reconstructed by AutoSPECT Pro and the results will likely be erroneous.",
      "applies": "this device",
      "via": "K090403"
    }
  ],
  "eu_market_availability": null,
  "properties": [
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          ]
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          "values": [
            {
              "value": "21 CFR Part 892.1200",
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              "value": "Radiology",
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        {
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            }
          ]
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      ]
    }
  ]
}