Clearance Summary
FLAT PANEL DETECTOR received FDA 510(k) clearance under submission number K121444, sponsored by Canon, Inc. - Medical Equpment Group. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2012-06-07.
- Submission: K121444
- Applicant / Sponsor: Canon, Inc. - Medical Equpment Group
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 2012-06-07
Classification & Regulation
This clearance is catalogued under FDA product code OWB and 21 CFR 892.1650, within the Radiology review panel as a Class II device.