vascuCAP

GUDID B745A40

ELUCID BIOIMAGING INC.

CT system application software

• Primary Device ID: B745A40
• NIH Device Record Key: a72dd822-b5e0-4042-8cf6-1ba970709fa9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: vascuCAP
• Version Model Number: A.1.2
• 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: true
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B745A40 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183012

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: 2019-05-08
• Device Publish Date: 2019-04-30

On-Brand Devices [vascuCAP]

• B745A40: A.1.2
• B745VASCUCAPA2: A.2