# K973073: DRTS Image Intensifier Drape

- Pathway: 510(k) (Traditional)
- Applicant: Minrad, Inc.
- Decided: Oct 8, 1997 after 51 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The MINRAD™ DRTS™ Image Intensifier Drape is intended to provide a closed. sterilc cover for the Image Intensifier cud of all presently marketed, mobile C-Arm X-ray machincs

Source page: https://510kreport.com/device/K973073
Methodology: https://510kreport.com/methodology