Clearance Summary
HDRS-1 SYSTEM received FDA 510(k) clearance under submission number K915367, sponsored by Precision Radiation Measurement, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1992-04-06.
- Submission: K915367
- Applicant / Sponsor: Precision Radiation Measurement, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5700
- Decision date: 1992-04-06
Classification & Regulation
This clearance is catalogued under FDA product code JAQ and 21 CFR 892.5700, within the Radiology review panel as a Class II device.