Philips Iqon Spectral CT

510(k) K133674

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

6 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK133674	Date21 Nov 2014Cleared	StatusActive

6 recalls · FDA

- Terminated Z-1414-2018 FDA Class II initiated 8 Feb 2018
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
- Terminated Z-0841-2018 FDA Class II initiated 11 Jan 2018
23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues include: " Software errors that may result in CT spectral images misrepresentation or incorrect treatment; " Software errors that may result in partial set of images or inability to generate CT images.
- Terminated Z-0333-2018 FDA Class II initiated 8 Nov 2017
There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry.
- Terminated Z-1006-2017 FDA Class II initiated 16 Dec 2016
Multiple issues have caused the device to result in CT rescans or incorrect scan location or misrepresentation of image results.
- Terminated Z-0705-2017 FDA Class II initiated 14 Nov 2016
A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Applications while filming, saving and annotating images
- Terminated Z-0598-2017 FDA Class III initiated 13 Oct 2016
The product label does not include the correct current rating.

1 jurisdiction

United States — FDA 510(k) Active

510(k)