# K992306: Samsung Raypax Display Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Sds Co., Ltd.
- Decided: Sep 22, 1999 after 75 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 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)
- K973959: Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview Software, Olicon Imaging Systems, Inc. (1997) Summary page 1.

## Indications for use
The Samsung RAYPAX™ Display Workstation is a device that receives digital images and data from various image sources, (including but not limited to CT Scanners, MR Scanners, Ultrasound Systems, R/F Units, Computed & Direct Radiographic devices, secondary capture devices, film scanners, imaging gateways, or other imaging sources). Images and data can be stored, communicated, processed, and displayed within the workstation or across computer networks at distributed locations. The typical users of this system are trained professionals, including but not limited to physicians, nurses, and medical technicians.

Source page: https://510kreport.com/device/K992306
Methodology: https://510kreport.com/methodology