The following data is part of a premarket notification filed by Elucid Bioimaging Inc. with the FDA for Elucidvivo A.3.
| Device ID | K221463 |
| 510k Number | K221463 |
| Device Name: | ElucidVivo A.3 |
| Classification | System, Image Processing, Radiological |
| Applicant | Elucid Bioimaging Inc. 2 Park Plaza, Suite 700 Boston, MA 02116 |
| Contact | Doug Shufelt |
| Correspondent | Doug Shufelt Elucid Bioimaging Inc. 2 Park Plaza, Suite 700 Boston, MA 02116 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-19 |
| Decision Date | 2022-06-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B745ELUCIDVIVOA3 | K221463 | 000 |