510(k) K201503
K201503 is an FDA 510(k) premarket notification submitted by Osko, Inc. for the device "Edge Air(1417) Digital Flat Panel X-ray Detector". The FDA issued a decision of Substantially Equivalent on Jun 29, 2020. The device falls under product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)), a Class II device regulated under 21 CFR 892.1680. Osko, Inc. has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 29, 2020
- Date Received
- Jun 5, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type
- 510(k)