# K040577: Somatom Project P30L

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Systems, Inc.
- Decided: Mar 22, 2004 after 18 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K982349 (1998). 2 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013522: Somatom P30 CT Systems, Siemens Medical Systems, Inc. (2001) Summary page 1.

## Most influential descendants
- K043087: Somatom Care Contrast CT (2004), 2 descendants of its own
- K061976: Ckis-004A Injector Synchronization Option (2006), 1 descendant of its own
- K140232: Syngo CT 2014A (Somaris/5 VB42) for Somatom Emotion & Sensation Family CT (2014), 0 descendants of its own
- K082960: GE Xtreme Injector Option (2008), 0 descendants of its own
- K043086: Somatom Respiratory Gating (2004), 0 descendants of its own

## Recalls of this device
- Feb 15, 2016 · Class II · Z-1307-2016: 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-0796-06: When using the LungCare feature in the SOMATOM CT Systems some marks made on CT images may not be saved.

## Indications for use
The Siemens SOMATOM P30L 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/K040577
Methodology: https://510kreport.com/methodology