# K992131: Samsung Raypax Long Term Archive

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Sds Co., Ltd.
- Decided: Sep 13, 1999 after 82 days
- Product code: LMB (Device, Digital Image Storage, Radiological)
- Device class: 1
- Regulation: 21 CFR 892.2010
- 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 K922164 (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)
- K973463: Olicon Imaging Systems, Inc. Archive Systems, NT Archive, 02ARCHIVE, Archive, O Tech, Inc. (1997) Summary page 1.

## Indications for use
The Samsung RAYPAX™ Archive will be used to store & retrieve digital medical images and information about the images. The typical users are trained medical professionals.

Source page: https://510kreport.com/device/K992131
Methodology: https://510kreport.com/methodology