The following data is part of a premarket notification filed by Quantib Bv with the FDA for Quantib Prostate.
| Device ID | K202501 |
| 510k Number | K202501 |
| Device Name: | Quantib Prostate |
| Classification | System, Image Processing, Radiological |
| Applicant | Quantib BV Westblaak 106 Rotterdam, NL 3012 Km |
| Contact | Floor Van Leeuwen |
| Correspondent | Floor Van Leeuwen Quantib BV Westblaak 106 Rotterdam, NL 3012 Km |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-31 |
| Decision Date | 2020-10-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08719689791056 | K202501 | 000 |
| 08719689791117 | K202501 | 000 |
| 08719689791131 | K202501 | 000 |