Clearance Summary
MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U received FDA 510(k) clearance under submission number K043293, sponsored by Acrorad Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2004-12-17.
- Submission: K043293
- Applicant / Sponsor: Acrorad Co., Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1200
- Decision date: 2004-12-17
Classification & Regulation
This clearance is catalogued under FDA product code KPS and 21 CFR 892.1200, within the Radiology review panel as a Class II device.