Clearance Summary
GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415 received FDA 510(k) clearance under submission number K901832, sponsored by Amersham Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1990-07-09.
- Submission: K901832
- Applicant / Sponsor: Amersham Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1170
- Decision date: 1990-07-09
Classification & Regulation
This clearance is catalogued under FDA product code KGI and 21 CFR 892.1170, within the Radiology review panel as a Class II device.