Clearance Summary
GAMMA 600 NUCLEAR MEDICINE COMPUTER received FDA 510(k) clearance under submission number K903469, sponsored by Strichman Medical Equipment, 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 1991-02-04.
- Submission: K903469
- Applicant / Sponsor: Strichman Medical Equipment, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1100
- Decision date: 1991-02-04
Classification & Regulation
This clearance is catalogued under FDA product code IYX and 21 CFR 892.1100, within the Radiology review panel as a Class I device.