# K960635: Pulmo CT with Reference Database for the Somatom Plus and Plus 4 Computed Tomography Systems

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Apr 3, 1996 after 49 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.
211 later devices descend from it; 1 cites it directly.
1 of 212 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) Pulmo CT option in SOMATOM Plus CT: named in the summary without a submission number
- (no number) Pulmo CT option in SOMATOM Plus 4 CT: named in the summary without a submission number

## Most influential descendants
- K071513: Inspace 4D Software Package with Extended Functionality (2007), 210 descendants of its own
- K073003: Syngo Dual Energy with Extended Functionally (2008), 168 descendants of its own
- K083524: Syngo Dual Energy with Extended Funationally (2009), 117 descendants of its own
- K112020: Syngo.CT Vascular Analysis (2011), 99 descendants of its own
- K123920: Syngo.Via (2013), 63 descendants of its own

## Indications for use
The Pulmo CT with Reference Database is intended for diagnostic imaging. It provides highly reproducible CT values for pulmonary tissue, which is essential for follow up examinations and for providing quantitative support for diagnosis.

Source page: https://510kreport.com/device/K960635
Methodology: https://510kreport.com/methodology