Clearance Summary
Models 2200DR and 1600DR Digital Stationary Radiographic Systems received FDA 510(k) clearance under submission number K151219, sponsored by Beijing Polycon Medical Engineering Company. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2015-08-04.
- Submission: K151219
- Applicant / Sponsor: Beijing Polycon Medical Engineering Company
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2015-08-04
Classification & Regulation
This clearance is catalogued under FDA product code KPR and 21 CFR 892.1680, within the Radiology review panel as a Class II device.