# K965004: C.a.R.E. Vision for the Somatom Plus 4 CT Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Mar 11, 1997 after 85 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have 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) SOMATOM Plus 4 CT: named in the summary without a submission number
- (no number) Real Time Reconstruction System Option for Xpress /SX CT System: named in the summary without a submission number

## Most influential descendants
- K983140: CT Biopsyview (1998), 0 descendants of its own

## Indications for use
The C.A.R.E. VISION is intended to be used for instant display of CT images during interventional procedures using CT scanners. Instant image reconstruction of 3-9 images per second allows the physician to watch the placement of an interventional instrument real time.

Source page: https://510kreport.com/device/K965004
Methodology: https://510kreport.com/methodology