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 |