# K120995: Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software Product

- Pathway: 510(k) (Traditional)
- Applicant: Erad, Inc.
- Decided: Dec 3, 2012 after 245 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 K954678 (1996). 22 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061421: Erad Pacs, Erad, Inc. (2006) Summary page 1.

## Most influential descendants
- K152977: DG Pacs (2016), 4 descendants of its own
- K202335: Ambra ProViewer (2020), 2 descendants of its own
- K241223: eRAD PACS (2024), 0 descendants of its own
- K240839: OpenRad Cloud (2024), 0 descendants of its own
- K231360: Ambra PACS (2023), 0 descendants of its own

## Indications for use
eRAD PACS! eRAD RIS/PACS is a PACS software product used to receive DICOM images, scheduling information and textual report, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. The eRAD PACS! eRAD RIS/PACS viewer software is intended for use as a primary diagnostic and analysis tool for diagnostic images. eRAD PACS! eRAD RIS/PACS is for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information. The eRAD PACS! eRAD RIS/PACS viewer displays images from CT, computed radiography, MRI, mammography, nuclear medicine, PET, secondary capture, ultrasound, x-ray angiography, x-ray fluoroscopy and visible light modalities. Lossy compressed mammography images and digitized film screen mammography images must not be reviewed for primary image interpretations. Mammography images may only be interpreted using an FDA approved monitor that offers at least 5 mega-pixel resolution and meets other technical specifications reviewed and accepted by FDA.

Source page: https://510kreport.com/device/K120995
Methodology: https://510kreport.com/methodology