# K081948: Raypax System

- Pathway: 510(k) (Traditional)
- Applicant: Raypax, Inc.
- Decided: Sep 19, 2008 after 73 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: 5 generations back to K913770 (1991). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043415: Centricity Pacs System, Ge Medical Systems Information Technologies (2005) Summary page 1.

## Indications for use
The RAYPAX System is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images acquired from devices such as Computed Tomography (CT), Magnetic Resonance (MR), Computed Radiography (CR), Digital X-Ray (DX), Digital Mammography (MG), Ultrasound, (US), Nuclear Medicine (NM), Positron Emission Tomography (PET), X-Ray Angiography (XA), Film Scanners, and any other DICOM supporting devices. The clients of RAYPAX System are intended for diagnostic and analysis tool by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. QCW(Quality control Workstation) is intended for technicians to verify exams. DW(Diagnostic Workstation) and RW(Review Workstation) is intended for radiologists to perform a diagnostic analysis of the exams and WCC(Web Client Component) is intended for the clinical review of physicians. Net Point and Lite are intended to acquire exams from remote facilities through the Internet. Net, Exp and Web client versions are intended for a remote access to the images through the Internet. For the digital mammography images, to be viewed for primary interpretation, images must be acquired from an FDA approved Mammography device for primary interpretation and viewed on a display system with at least 5 Mega Pixel of resolution and has been cleared by the FDA for diagnosis of digital mammography images. Furthermore, the Mammography device must be able to provide, to the RAYPAX System, a viewable DICOM 'for presentation' mammography image. Images that are printed to film must be printed using a FDA approved printer for the diagnosis of digital mammography images.

Source page: https://510kreport.com/device/K081948
Methodology: https://510kreport.com/methodology