# K052460: Powerserver, Powerreader, Gateway and Powercache

- Pathway: 510(k) (Traditional)
- Applicant: Ramsoft, Inc.
- Decided: Sep 21, 2005 after 14 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). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031562: Ramsoft Pacs, Model 3.0, Ramsoft, Inc. (2003) Summary page 1.
- K043415: Centricity Pacs System, Ge Medical Systems Information Technologies (2005) Summary page 1.

## Indications for use
This software is used with general purpose computing hardware for the storage, review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from imaging devices such as CR, CT, DX, MR, MG, NM, PT, RF, US, XA, film digitizers, and document scanners, and other DICOM devices. With appropriate hardware, the software is intended for use as a primary diagnostic, analysis, and review tool for use by trained healthcare professionals. It is the user's responsibility to ensure image quality, lighting, and image compression ratios are suitable for the clinical application. Digitized film should not be used for primary diagnosis in mammography. Lossy compression should not be used for primary diagnosis in mammography. Primary diagnosis on digital mammograms should not be done on any monitors other than those specifically cleared by the FDA for digital mammography applications. Film printing for digital mammography should not be performed on any printers other than those specifically cleared by the FDA for digital mammography applications.

Source page: https://510kreport.com/device/K052460
Methodology: https://510kreport.com/methodology