The following data is part of a premarket notification filed by Quibim S.l. with the FDA for Quibim Precision Prostate (qp-prostate).
| Device ID | K203582 |
| 510k Number | K203582 |
| Device Name: | QUIBIM Precision Prostate (qp-Prostate) |
| Classification | System, Image Processing, Radiological |
| Applicant | QUIBIM S.L. Avenida Aragón 30, 12th Floor, Office I, 46021, Valencia (Spain) Valencia, ES 46021 |
| Contact | Angel Alberich Bayarri |
| Correspondent | John J. Smith Hogan Lovells US LLP 555 13th St NW Washington, DC 20005 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-07 |
| Decision Date | 2021-02-04 |