# K062878: Ezpacs, Version 3.0

- Pathway: 510(k) (Abbreviated)
- Applicant: Advanced Imaging Solutions, LLC
- Decided: Jun 27, 2007 after 274 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 K913475 (1991). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030781: Kodak Directview Pacs/Image Management System, Kodak Directview Workflow Manager,Kodak Directview CX/DX, Kodak Directvib, Eastman Kodak Company (2003) 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.

## Most influential descendants
- K100236: Stair Systems Pacs & Dicom Viewer (2010), 1 descendant of its own
- K112008: Touchpacs Suite (2012), 0 descendants of its own

## Indications for use
EZPACS® is intended for use by radiologists (for primary diagnosis), and other medical professionals who needs access to radiological images and reports. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Source page: https://510kreport.com/device/K062878
Methodology: https://510kreport.com/methodology