# K992112: Samsung Raypax Film Digitizer

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Sds Co., Ltd.
- Decided: Sep 9, 1999 after 79 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: 2 generations back to K934496 (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)
- K974315: Vidar VXR LS Laser Film Digitizer, Vidar Systems Corp. (1998) Summary page 1.

## Indications for use
The Samsung RAYPAX™ Film Digitizer is a digitizer intended to convert medical images and data into digital signals. The digital data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.

Source page: https://510kreport.com/device/K992112
Methodology: https://510kreport.com/methodology