# K040665: Somatom Sensation 64 and Sensation Cardiac

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Apr 2, 2004 after 29 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 5 (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.
136 later devices descend from it; 6 cite it directly.
1 of 139 devices in its family (counting itself) has 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
- 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
- K130901: Somatom Definition as Open (2014), 49 descendants of its own

## Recalls of this device
- Feb 15, 2016 · Class II · Z-1306-2016: 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-1305-2016: 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
- Sep 3, 2008 · Not classified · Z-0320-2009: software error - does not allow protocol to properly synchronize with ECG triggers
- Sep 3, 2008 · Not classified · Z-0321-2009: software error - does not allow protocol to properly synchronize with ECG triggers
- Mar 9, 2006 · Not classified · Z-0795-06: 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 P30F 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/K040665
Methodology: https://510kreport.com/methodology