The following data is part of a premarket notification filed by Quantib Bv with the FDA for Quantib Prostate.
| Device ID | K221106 |
| 510k Number | K221106 |
| Device Name: | Quantib Prostate |
| Classification | System, Image Processing, Radiological |
| Applicant | Quantib BV Westblaak 106 Rotterdam, NL 3012 KM |
| Contact | Arnault Massink |
| Correspondent | Arnault Massink Quantib BV Westblaak 106 Rotterdam, NL 3012 KM |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-15 |
| Decision Date | 2022-05-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08719689791186 | K221106 | 000 |
| 08719689791209 | K221106 | 000 |