# K982955: Silhouette VR

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Nov 4, 1998 after 72 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 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 no predicate by number.

## Most influential descendants
- K103448: Brivo XR385 (2011), 4 descendants of its own
- K141381: Duradiagnost (2014), 3 descendants of its own
- K163410: DigitalDiagnost C50 (2017), 1 descendant of its own
- K201725: DigitalDiagnost C50 (2020), 0 descendants of its own
- K201640: DuraDiagnost (2020), 0 descendants of its own

## Recalls of this device
- Mar 29, 2019 · Class II · Z-1755-2019: There has been a reported incident of a Distar CRT monitor that has fallen off the monitor wall mount related to product aging.

## Indications for use
The Silhouette VR is indicated for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.

Source page: https://510kreport.com/device/K982955
Methodology: https://510kreport.com/methodology