# K061421: Erad Pacs

- Pathway: 510(k) (Traditional)
- Applicant: Erad, Inc.
- Decided: Jul 25, 2006 after 64 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: 4 generations back to K954678 (1996). 21 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013630: Isite Radiology, Stentor, Inc. (2001) Summary page 1.
- K022292: Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for Cardiology Clinical Review Satation,Impax Ortho, Agfa Corp. (2002) Summary page 1.
- K012097: Vortex, Ultravisual Medical Systems (2001) Summary page 1.
- K042313: Integradweb MPR/Mip, Dynamic Imaging, Inc. (2004) Summary page 1.
- (no number) Stentor's iVault: named in the summary without a submission number

## Most influential descendants
- K120995: Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software Product (2012), 7 descendants of its own
- K152977: DG Pacs (2016), 4 descendants of its own
- K132799: Clariso Pacs (2013), 4 descendants of its own
- K151957: BOX DICOM Viewer (2015), 3 descendants of its own
- K202335: Ambra ProViewer (2020), 2 descendants of its own

## Indications for use
eRAD PACS is a PACS and teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. eRAD PACS is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information.

Source page: https://510kreport.com/device/K061421
Methodology: https://510kreport.com/methodology