The following data is part of a premarket notification filed by Quantib B.v. with the FDA for Quantib Nd.
| Device ID | K213737 |
| 510k Number | K213737 |
| Device Name: | Quantib ND |
| Classification | System, Image Processing, Radiological |
| Applicant | Quantib B.V. Westblaak 106 Rotterdam, NL 3012km |
| Contact | Floor Van Leeuwen |
| Correspondent | Floor Van Leeuwen Quantib B.V. 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 | 2021-11-29 |
| Decision Date | 2022-01-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08719689791179 | K213737 | 000 |
| 08719689791216 | K213737 | 000 |
| 08719689791261 | K213737 | 000 |