ElucidVivo
GUDID B745ELUCIDVIVOA3
ELUCID BIOIMAGING INC.
CT system application software| Primary Device ID | B745ELUCIDVIVOA3 |
| NIH Device Record Key | 63ae0cf5-ee8a-4881-b4c6-e2f88867c5b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ElucidVivo |
| Version Model Number | A.3 |
| Company DUNS | 079267473 |
| Company Name | ELUCID BIOIMAGING INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B745ELUCIDVIVOA3 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K221463
FDA Product Code
| LLZ | System, image processing, radiological |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-09 |
| Device Publish Date | 2022-08-01 |
Devices Manufactured by ELUCID BIOIMAGING INC.
| B745ELUCIDVIVOA3 - ElucidVivo | 2022-08-09 |
| B745ELUCIDVIVOA3 - ElucidVivo | 2022-08-09 |
| B745VASCUCAPA2 - vascuCAP | 2022-02-25 |
| B745A40 - vascuCAP | 2019-05-08 |
Trademark Results [ElucidVivo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ELUCIDVIVO 97843917 not registered Live/Pending |
Elucid Bioimaging Inc. 2023-03-17 |
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