# K991922: Digital Imaging System (BSR)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 1, 1999 after 86 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K933664 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933664: Polytron T.O.P. (Time, Operation, Performance), Siemens Gammasonics, Inc. (1993) Summary page 1.
- K984545: Release 2 of Philips Integris Series (V5000, BV5000, H5000, BH5000, HM2000) Systems, Philips Medical Systems North America, Inc. (1999) Summary page 1.

## Indications for use
The Digital Imaging Systems (BSR), are intended for use in acquiring diagnosic quality images during cardiac, angiographic, vascular and neurovascular applications.

Source page: https://510kreport.com/device/K991922
Methodology: https://510kreport.com/methodology