Clearance Summary
Aura DR 43C-AG flat panel detector received FDA 510(k) clearance under submission number K151014, sponsored by Abyzr 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 2015-07-13.
- Submission: K151014
- Applicant / Sponsor: Abyzr Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2015-07-13
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.