# K151737: MedicVOD System

- Pathway: 510(k) (Traditional)
- Applicant: Orpheus Medical, Ltd.
- Decided: Feb 25, 2016 after 244 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: 10 generations back to K931783 (1993). 50 ancestors in all.
No later device cites it as a predicate yet.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123426: Medicvod, Medicast, Medishow, Medisearch, Central Storage System - CSS, Orpheus Medical, Ltd. (2013) Summary page 4.

## Indications for use
The MedicVOD System is a picture archival and communications systems (PACS) that is intended for image capturing, archiving, displaying and recording of audio/video sequences and patient data during a procedure. The system allows for capture and annotation of the surgical procedure for documentation purposes and for viewing at a later time either locally or on a secure distributed network. The captured audio/video sequences can be broadcasted in real-time with video-conferencing capability during the broadcast. Information captured and stored by the system are for viewing and reference purposes only and are not intended for primary diagnosis.

Source page: https://510kreport.com/device/K151737
Methodology: https://510kreport.com/methodology