510(k) K223009
K223009 is an FDA 510(k) premarket notification submitted by Allengers Medical Systems Limited for the device "Wireless/Wired X-Ray Flat Panel Detectors". The FDA issued a decision of Substantially Equivalent on November 27, 2022. 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. Allengers Medical Systems Limited has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 27, 2022
- Date Received
- September 29, 2022
- Clearance Type
- Traditional
- 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