# K141561: VM Pacs with VM Medical Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Visual Medica
- Decided: Jan 16, 2015 after 218 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: 7 generations back to K942120 (1994). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123174: Centricity Pacs-IW with Universal Viewer, GE Healthcare (2012) Summary page 4.

## Indications for use
VM PACS is designed to Store Medical Dicom Images and leave them available to be used for diagnostics or transferred to other Dicom devices. VM PACS is not meant to create or modify DICOM images. VM PACS store the images and the Data Set send by an DICOM compatible image diagnostic equipment and store them making them available to be access by a workstation or viewer, or been transfer to another Dicom Compatible device. VM PACS does not modify the images store in it. User Graphic interface VM Medical Workstation is a complete Workstation which provides diagnostic tools for image diagnose, for CT, MR, PT, CR, DX, NM, MG, XA, RF, SC, US and ES, as zoom, Window & Level variation and presets, measurements and a complete set of diagnostics tools and includes a report tool for the studies. Lossy compressed mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA. VM Clinical Viewer is the web access interface of VM PACS, which allows integration with any Operating System, brings to the institution the capacity to access the images remotely. VM Clinical Viewer allows the specialist consultation and the communication between radiologists and referring physicians. The system enables authorized external users to have access to specific patient studies, is not intended for diagnostic purposes when used on mobile devices.

Source page: https://510kreport.com/device/K141561
Methodology: https://510kreport.com/methodology