The following data is part of a premarket notification filed by Quantib Bv with the FDA for Quantib Brain 1.
| Device ID | K153351 |
| 510k Number | K153351 |
| Device Name: | Quantib Brain 1 |
| Classification | System, Image Processing, Radiological |
| Applicant | QUANTIB BV WESTBLAAK 106 Rotterdam, NL Nl-3012 Km |
| Contact | Floor Van Leeuwen |
| Correspondent | Floor Van Leeuwen QUANTIB BV WESTBLAAK 106 Rotterdam, NL 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 | 2015-11-20 |
| Decision Date | 2016-06-17 |
| Summary: | summary |