Clearance Summary
DIGITAL RADIOGRAPHY, FLEXDR C30 received FDA 510(k) clearance under submission number K082347, sponsored by Konica Minolta Technoproduct Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2008-11-18.
- Submission: K082347
- Applicant / Sponsor: Konica Minolta Technoproduct Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2008-11-18
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.