The following data is part of a premarket notification filed by Quantib Bv with the FDA for Quantib Brain 1.2.
| Device ID | K163013 |
| 510k Number | K163013 |
| Device Name: | Quantib Brain 1.2 |
| Classification | System, Image Processing, Radiological |
| Applicant | Quantib BV Westblaak 106 Rotterdam, NL 3012km |
| Contact | Rudolf Scholte |
| Correspondent | Rudolf Scholte Quantib BV Westblaak 106 Rotterdam, NL 3012km |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-28 |
| Decision Date | 2017-01-06 |
| Summary: | summary |