Clearance Summary
DIGITAL RADIOGRAPHY received FDA 510(k) clearance under submission number K102012, sponsored by Canon Inc. -Medical Equipment 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 2010-08-17.
- Submission: K102012
- Applicant / Sponsor: Canon Inc. -Medical Equipment Group
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2010-08-17
Classification & Regulation
This clearance is catalogued under FDA product code MQB and 21 CFR 892.1680, within the Radiology review panel as a Class II device.