K210931 is an FDA 510(k) clearance for the Libby IAAA v1.0. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Dyad Medical, Inc. (Boston, US). The FDA issued a Cleared decision on December 17, 2021, 263 days after receiving the submission on March 29, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K210931 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 2021 |
| Decision Date | December 17, 2021 |
| Days to Decision | 263 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LLZ - System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |