Clearance Summary
DUAL RADIATION TARGETING SYSTEM DRTS DRAPE received FDA 510(k) clearance under submission number K973162, sponsored by Hogan & Hartson. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1997-11-20.
- Submission: K973162
- Applicant / Sponsor: Hogan & Hartson
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.5780
- Decision date: 1997-11-20
Classification & Regulation
This clearance is catalogued under FDA product code IWE and 21 CFR 892.5780, within the Radiology review panel as a Class I device.