The following data is part of a premarket notification filed by Allengers Medical Systems Limited with the FDA for Wireless/wired X-ray Flat Panel Detectors.
| Device ID | K223009 |
| 510k Number | K223009 |
| Device Name: | Wireless/Wired X-Ray Flat Panel Detectors |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Allengers Medical Systems Limited FDA Hall Unit-2, Bhankarpur, Mubarakpur Road Derabassi, Distt. Mohali, IN 140507 |
| Contact | Sanjeev K. Marjara |
| Correspondent | Sanjeev K. Marjara Allengers Medical Systems Limited FDA Hall Unit-2, Bhankarpur, Mubarakpur Road Derabassi, Distt. Mohali, IN 140507 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-29 |
| Decision Date | 2022-11-27 |