VeraLook CTC CAD CT-102-V-US, CT-102-V, CT-103, D70070, D70071, D70

GUDID 00858012005885

VeraLook® CTC CAD Software is intended to automatically detect potential polyps in CT Colonography exams. The identified polyps can then be highlighted to the interpreting physician after initial review of the CTC exam with the intent of identifying additional potential polyps that may not have been identified on initial review.

Icad, Inc.

CT system application software

• Primary Device ID: 00858012005885
• NIH Device Record Key: a06aa61d-c928-4b6f-9a56-abfb72ce0173
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VeraLook CTC CAD
• Version Model Number: V1.0
• Catalog Number: CT-102-V-US, CT-102-V, CT-103, D70070, D70071, D70
• Company DUNS: 108870254
• Company Name: Icad, 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: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-866-280-2239
• Email: service@icadmed.com
• Phone: 1-866-280-2239
• Email: service@icadmed.com
• Phone: 1-866-280-2239
• Email: service@icadmed.com
• Phone: 1-866-280-2239
• Email: service@icadmed.com
• Phone: 1-866-280-2239
• Email: service@icadmed.com
• Phone: 1-866-280-2239
• Email: service@icadmed.com
• Phone: 1-866-280-2239
• Email: service@icadmed.com
• Phone: 1-866-280-2239
• Email: service@icadmed.com
• Phone: 1-866-280-2239
• Email: service@icadmed.com
• Phone: 1-866-280-2239
• Email: service@icadmed.com
• Phone: 1-866-280-2239
• Email: service@icadmed.com
• Phone: 1-866-280-2239
• Email: service@icadmed.com
• Phone: 1-866-280-2239
• Email: service@icadmed.com
• Phone: 1-866-280-2239
• Email: service@icadmed.com
• Phone: 1-866-280-2239
• Email: service@icadmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858012005885 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091529

FDA Product Code

• JAK: System, X-Ray, Tomography, Computed

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: 2021-05-25
• Device Publish Date: 2021-05-17

On-Brand Devices [VeraLook CTC CAD]

• 00858012005908: VeraLook® CTC CAD Software is intended to automatically detect potential polyps in CT Colonogra
• 00858012005915: VeraLook® CTC CAD Software is intended to automatically detect potential polyps in CT Colonogra
• 00858012005892: VeraLook® CTC CAD Software is intended to automatically detect potential polyps in CT Colonogra
• 00858012005885: VeraLook® CTC CAD Software is intended to automatically detect potential polyps in CT Colonogra