The following data is part of a premarket notification filed by Screenpoint Medical B.v. with the FDA for Transpara 1.7.2.
| Device ID | K221347 |
| 510k Number | K221347 |
| Device Name: | Transpara 1.7.2 |
| Classification | Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer |
| Applicant | ScreenPoint Medical B.V. Mercator II, 7th Floor, Teornooiveld 300 Nijmegen, NL 6525EC |
| Contact | Robin Barwegen |
| Correspondent | Robin Barwegen ScreenPoint Medical B.V. Mercator II, 7th Floor, Teornooiveld 300 Nijmegen, NL 6525EC |
| Product Code | QDQ |
| CFR Regulation Number | 892.2090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-09 |
| Decision Date | 2022-08-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08720387058013 | K221347 | 000 |