# K973162: Dual Radiation Targeting System DRTS Drape

- Pathway: 510(k) (Traditional)
- Applicant: Hogan & Hartson
- Decided: Nov 20, 1997 after 90 days
- Product code: IWE (Monitor, Patient Position, Light-Beam)
- Device class: 1
- Regulation: 21 CFR 892.5780
- 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. The FDA summary names its predicate without a number.
- (no number) Microtek Medical, Inc. -- Large C-Arm Drape Product Number 4982: named in the summary without a submission number
- (no number) Contour Fabricators Number CFI-600, equipment drape: named in the summary without a submission number

## Indications for use
The DRTS™ Drape is to be used in an operating room environment to cover the DRTS™ device when it is mounted on an x-ray machine for procedures wherein it is deemed desirable to protect the DRTS™ device from contamination with patient fluids or tissues.

Source page: https://510kreport.com/device/K973162
Methodology: https://510kreport.com/methodology