Somatom P30 CT Systems

510(k) K013522

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

9 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	NumberK013522	Date7 Nov 2001Cleared	StatusActive

9 recalls · FDA

2 recalls, same reason
- Terminated Z-1303-2016 FDA Class II initiated 15 Feb 2016
- Terminated Z-1304-2016 FDA Class II initiated 15 Feb 2016
Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems in conjunction with the use of the cardio licenses "Cardio Pro" and "Cardio Retro".
- Terminated Z-0794-06 FDA Unclassified (pre-2012) initiated 9 Mar 2006
When using the LungCare feature in the SOMATOM CT Systems some marks made on CT images may not be saved.
4 recalls, same reason
- Terminated Z-0159-05 FDA Unclassified (pre-2012) initiated 28 Sep 2004
- Terminated Z-0162-05 FDA Unclassified (pre-2012) initiated 28 Sep 2004
- Terminated Z-0158-05 FDA Unclassified (pre-2012) initiated 28 Sep 2004
- Terminated Z-0160-05 FDA Unclassified (pre-2012) initiated 28 Sep 2004
Calcium Scoring feature on this devices is not closing properly after patient's exams.
- Terminated Z-0842-03 FDA Unclassified (pre-2012) initiated 11 Oct 2002 on shared 510(k) K013522
Perfusion CT is displaying a higher gray and color values than normal. A software problem.
- Terminated Z-0322-03 FDA Unclassified (pre-2012) initiated 10 Jul 2002
Head holder cannot be properly secured on the table top.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1 jurisdiction

United States — FDA 510(k) Active

510(k)