The following data is part of a premarket notification filed by Quantib Bv with the FDA for Quantib Nd.
| Device ID | K182564 |
| 510k Number | K182564 |
| Device Name: | Quantib ND |
| 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 | 2018-09-18 |
| Decision Date | 2018-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08719689791148 | K182564 | 000 |