The following data is part of a premarket notification filed by Exini Diagnostics Ab with the FDA for Apromise X.
| Device ID | K220590 |
| 510k Number | K220590 |
| Device Name: | APROMISE X |
| Classification | System, Image Processing, Radiological |
| Applicant | EXINI Diagnostics AB Ideon Science Park, Scheelevagen 27 Lund, SE Se-223 70 |
| Contact | Aseem Anand |
| Correspondent | Donna-bea Tillman Biologics Consulting Group 1555 King Street Alexandria, VA 22314 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-01 |
| Decision Date | 2022-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350002336021 | K220590 | 000 |
| 07350002337028 | K220590 | 000 |