# K013709: Hill-Rom Primaview Monitor System

- Pathway: 510(k) (Traditional)
- Applicant: Hill-Rom, Inc.
- Decided: Nov 16, 2001 after 8 days
- Product code: FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology)
- 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: 1 generation back to K885042 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K885042: Sony Trinitron Color Video Monitor PVM-1343MD, Sony Medical Electronics Co. (1988) Summary page 4.

## Indications for use
The Hill-Rom PrimaView Monitor System is indicated for use in providing the clinician with a color video display of images that are generated from endoscopic, laproscopic or similar equipment (not supplied by Hill-Rom) during surgical procedures. This system may also be used to display radiographic images for reference only.

Source page: https://510kreport.com/device/K013709
Methodology: https://510kreport.com/methodology