K163013 is an FDA 510(k) clearance for the Quantib Brain 1.2. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Quantib B.V. (Rotterdam, NL). The FDA issued a Cleared decision on January 6, 2017, 70 days after receiving the submission on October 28, 2016.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K163013 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 2016 |
| Decision Date | January 06, 2017 |
| Days to Decision | 70 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LLZ - System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |