# K955457: Digiscan 2 Plus

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 18, 1996 after 202 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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 K924459 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924459: Digiscan 2, Siemens Medical Solutions USA, Inc. (1992) Summary page 2.

## Indications for use
The DIGISCAN 2 PLUS recording system may be used for all radiographic exposures for which conventional cassettes are used, such as pediatrics, trauma, bone, neuro, GI, mobile radiography and vascular radiography.

Source page: https://510kreport.com/device/K955457
Methodology: https://510kreport.com/methodology