# Autospect

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/autospect-kps>
- Manufacturer: [Philips Medical Systems (Cleveland), Inc.](https://devicerts.com/manufacturers/philips-medical-systems-cleveland-inc) (United States)
- Name in the registry: AUTOSPECT
- Device class: Class II (US FDA)
- FDA product code: KPS

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K090403 · decision 2009-03-31 · decision SESE · status: Active

## Recalls

- Z-1504-2016 · Class II · terminated · initiated 2016-03-04: 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.
- Z-1505-2016 · Class II · terminated · initiated 2016-03-04: 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.

## Identifiers

- 510(k) Number: K090403 [FDA 510(k)]
- FDA product code: KPS [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 892.1200 [FDA 510(k)]
- Advisory committee: Radiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Autospect, Philips Medical Systems (Cleveland), Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/autospect-kps (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/autospect-kps.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). 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
- 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.