# K013522: Somatom P30 CT Systems

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Systems, Inc.
- Decided: Nov 7, 2001 after 15 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K982349 (1998). 1 ancestor in all.
142 later devices descend from it; 5 cite it directly.
1 of 144 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982349: Somatom Plus 4WITH Volume Zoom CT Scanners, Siemens Medical Solutions USA, Inc. (1998) Summary page 2.

## Most influential descendants
- K040665: Somatom Sensation 64 and Sensation Cardiac (2004), 136 descendants of its own
- K060631: Biograph 64 and Biograph 40 (2006), 64 descendants of its own
- K081022: Somatom Definition, Model as/as+ (2008), 63 descendants of its own
- K081453: Biograph HD Family (2008), 62 descendants of its own
- K103127: Somatom Definition as (2011), 53 descendants of its own

## Recalls of this device
- Feb 15, 2016 · Class II · Z-1303-2016: 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 th
- Feb 15, 2016 · Class II · Z-1304-2016: 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 th
- Mar 9, 2006 · Not classified · Z-0794-06: When using the LungCare feature in the SOMATOM CT Systems some marks made on CT images may not be saved.
- Sep 28, 2004 · Not classified · Z-0160-05: Calcium Scoring feature on this devices is not closing properly after patient's exams.
- Sep 28, 2004 · Not classified · Z-0162-05: Calcium Scoring feature on this devices is not closing properly after patient's exams.
- Sep 28, 2004 · Not classified · Z-0158-05: Calcium Scoring feature on this devices is not closing properly after patient's exams.
- Sep 28, 2004 · Not classified · Z-0159-05: Calcium Scoring feature on this devices is not closing properly after patient's exams.
- Oct 11, 2002 · Not classified · Z-0842-03: Perfusion CT is displaying a higher gray and color values than normal. A software problem.
- Jul 10, 2002 · Not classified · Z-0322-03: Head holder cannot be properly secured on the table top.

## Indications for use
The SOMATOM P30 systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles. (*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

Source page: https://510kreport.com/device/K013522
Methodology: https://510kreport.com/methodology