# K062477: Amicas Vision Series Pacs, Model 4.3

- Pathway: 510(k) (Traditional)
- Applicant: Amicas, Inc.
- Decided: Oct 27, 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). 4 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022970: Amicas Light Beam Workstation, Model 1.0, Amicas, Inc. (2002) Summary page 1.

## Most influential descendants
- K073526: Amicas Vision Series Pacs, Model 5.5 (2008), 4 descendants of its own
- K082144: Amicas Pacs, Version 6.0 (2008), 3 descendants of its own
- K173475: Merge PACS (2017), 1 descendant of its own
- K192455: Merge PACS (2019), 0 descendants of its own
- K124048: Imageqube (2013), 0 descendants of its own

## Indications for use
Vision Series PACS 4.3 is designed and marketed for soft copy reading, communication, printing and storage of studies produced by digital modalities, to include Digital Mammography. Vision Series PACS receives images acquired from DICOM-compliant medical imaging systems, data from FDA-cleared Computer-Aided Detection systems and other FDA-cleared Image processing systems. Vision Series PACS imports images and render said images, upon request, within the AMICAS LightBeam Diagnostic Workstation utilizing both lossless (reversible) and lossy (irreversible) compression. To support the diagnostic interpretation of Mammography studies, Vision Series PACS will display the full fidelity DICOM image in a non-compressed format. Images will be rendered with patient and clinical infornation clearly displayed as part of the DICOM Overlay as required by MQSA, on monitors cleared by FDA for use in Digital Mammography. Lossy compressed mammography images and digitized film screen images should not be used for the purpose of primary diagnosis. Manmmographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Vision Series PACS formats and delivers images over a network to a FDA-cleared DICOM printer as requested and defined by the user. Vision Series PACS must be installed on suitable, commercial-standard hardware. It is the user's responsibility to ensure monitor quality, ambient light conditions and image compression ratios are consistent with the clinical application.

Source page: https://510kreport.com/device/K062477
Methodology: https://510kreport.com/methodology