The following data is part of a premarket notification filed by Screenpoint Medical B.v. with the FDA for Transpara 1.7.0.
| Device ID | K210404 |
| 510k Number | K210404 |
| Device Name: | Transpara 1.7.0 |
| Classification | Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer |
| Applicant | ScreenPoint Medical B.V. Mercator II, 7th Floor, Toernooiveld 300 Nijmegen, NL 6525ec |
| Contact | Umar Waqas |
| Correspondent | Umar Waqas ScreenPoint Medical B.V. Mercator II, 7th Floor, Toernooiveld 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 | 2021-02-10 |
| Decision Date | 2021-06-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08719326450131 | K210404 | 000 |