# K961343: Medvision Personal Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Medvision, Inc.
- Decided: Mar 13, 1997 after 339 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K923160 (1992). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961800: Head Mounted Display, Vista Medical Technologies, Inc. (1996). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K981999: Albatech Personal Monitor (1998), 1 descendant of its own
- K990731: Eastgate Personal Monitor (1999), 0 descendants of its own

## Indications for use
The MedVision Personal Monitor Models A and Models B are intended to display video image while mounted on the user's head.

Source page: https://510kreport.com/device/K961343
Methodology: https://510kreport.com/methodology