# K081022: Somatom Definition, Model as/as+

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 2, 2008 after 53 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K982349 (1998). 4 ancestors in all.
63 later devices descend from it; 4 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040665: Somatom Sensation 64 and Sensation Cardiac, Siemens Medical Solutions USA, Inc. (2004) Summary page 2.
- K063189: TSX-301A, Aquilion One CT System, Toshiba America Medical Systems, In.C (2006) Summary page 2.

## Most influential descendants
- K103127: Somatom Definition as (2011), 53 descendants of its own
- K130901: Somatom Definition as Open (2014), 49 descendants of its own
- K082220: Somatom Flash DS (2008), 36 descendants of its own
- K143401: SOMATOM Definition Edge (2015), 35 descendants of its own
- K143400: SOMATOM Definition AS/AS+ (2015), 32 descendants of its own

## Recalls of this device
- May 29, 2009 · Not classified · Z-1675-2009: Support mechanism may not engage properly due to improper stowage after opening which may result in internal component damage or potential injury.
- May 1, 2009 · Not classified · Z-1442-2009: Improper installation of accessory support arm, which could potentially result in the loosening of the arm over time causing it to fall.
- Dec 9, 2008 · Not classified · Z-0929-2009: possible improper installation of tilt transport lock/tilt limiter

## Indications for use
The Siemens SOMATOM Definition AS/ AS + (Project P46) 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/K081022
Methodology: https://510kreport.com/methodology