# K073526: Amicas Vision Series Pacs, Model 5.5

- Pathway: 510(k) (Traditional)
- Applicant: Amicas, Inc.
- Decided: Mar 12, 2008 after 86 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). 5 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062477: Amicas Vision Series Pacs, Model 4.3, Amicas, Inc. (2006) Summary page 1.

## Most influential descendants
- 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 5.5 is designed and marketed for soft copy reading, communication 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 information 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. Mammographic 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. Within Vision Series PACS 5.5, the AMICAS Real Time Worklist offers real-time status of radiology activity and provides customizable workflow management capabilities. Communication of critical results is facilitated and documented through optional, and configurable, components within the Real Time Worklist. Vision Reach is an optional component within the PACS 5.5 offering which provides clinicians secure, proactive communication and access to clinical reports and images. Order and Report information generated by HIS/RIS and report creation systems are received and displayed in PACS via the transmission of HL7 messaging. For this data, AMICAS is not the creator, but instead the downstream recipient which relies on the validity of data from said systems. 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/K073526
Methodology: https://510kreport.com/methodology