Clearance Summary
HAMAMATSU PET SCANNER, MODEL SHR-22000 received FDA 510(k) clearance under submission number K982171, sponsored by Hamamatsu Photonics K.K.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1998-09-17.
- Submission: K982171
- Applicant / Sponsor: Hamamatsu Photonics K.K.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1200
- Decision date: 1998-09-17
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.