The following data is part of a premarket notification filed by Allengers Medical Systems Limited with the FDA for Digix Fdx.
| Device ID | K192541 |
| 510k Number | K192541 |
| Device Name: | DigiX FDX |
| Classification | System, X-ray, Stationary |
| Applicant | Allengers Medical Systems Limited Bhankharpur, Mubarakpur Road Derabassi, Distt Mohali, IN 140507 |
| Contact | Sanjeev K. Marjara |
| Correspondent | Sanjeev K. Marjara Allengers Medical Systems Limited Bhankharpur, Mubarakpur Road Derabassi, Distt Mohali, IN 140507 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-16 |
| Decision Date | 2019-10-16 |