# K982349: Somatom Plus 4WITH Volume Zoom CT Scanners

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 30, 1998 after 86 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
143 later devices descend from it; 2 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)
- None. The FDA summary names its predicate without a number.
- (no number) Siemens SOMATOM Plus 4: named in the summary without a submission number
- (no number) GE CT/I: named in the summary without a submission number
- (no number) Elscint Twin Flash: named in the summary without a submission number
- (no number) SOMATOM Plus 4 Power: named in the summary without a submission number

## Most influential descendants
- K013522: Somatom P30 CT Systems (2001), 142 descendants of its own
- 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

## Indications for use
The Somatom Plus 4 with Volume Zoom package is 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 angels 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/K982349
Methodology: https://510kreport.com/methodology