The following data is part of a premarket notification filed by Dyad Medical, Inc. with the FDA for Libby Iaaa V1.0.
| Device ID | K210931 |
| 510k Number | K210931 |
| Device Name: | Libby IAAA V1.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | Dyad Medical, Inc. 215 Brighton Avenue, Suite 203 Boston, MA 02134 |
| Contact | Ronny Shalev |
| Correspondent | Rory A. Carrillo Dyad Medical, Inc. 215 Brighton Avenue, Suite 203 Boston, MA 02134 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-29 |
| Decision Date | 2021-12-17 |