Clearance Summary
RMS-1000 A.K.A. RAYTHEON MEDICAL SYSTEMS-1000 received FDA 510(k) clearance under submission number K853395, sponsored by Raytheon Medical Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1985-11-01.
- Submission: K853395
- Applicant / Sponsor: Raytheon Medical Systems
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1710
- Decision date: 1985-11-01
Classification & Regulation
This clearance is catalogued under FDA product code IZH and 21 CFR 892.1710, within the Radiology review panel as a Class II device.