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

• Phone: +1(617)304-9520
• Email: doug.shufelt@elucidbio.com
• Phone: +1(617)304-9520
• Email: doug.shufelt@elucidbio.com
• Phone: +1(617)304-9520
• Email: doug.shufelt@elucidbio.com
• Phone: +1(617)304-9520
• Email: doug.shufelt@elucidbio.com
• Phone: +1(617)304-9520
• Email: doug.shufelt@elucidbio.com
• Phone: +1(617)304-9520
• Email: doug.shufelt@elucidbio.com
• Phone: +1(617)304-9520
• Email: doug.shufelt@elucidbio.com
• Phone: +1(617)304-9520
• Email: doug.shufelt@elucidbio.com
• Phone: +1(617)304-9520
• Email: doug.shufelt@elucidbio.com
• Phone: +1(617)304-9520
• Email: doug.shufelt@elucidbio.com
• Phone: +1(617)304-9520
• Email: doug.shufelt@elucidbio.com

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