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 ID00858012005885
NIH Device Record Keya06aa61d-c928-4b6f-9a56-abfb72ce0173
Commercial Distribution StatusIn Commercial Distribution
Brand NameVeraLook CTC CAD
Version Model NumberV1.0
Catalog NumberCT-102-V-US, CT-102-V, CT-103, D70070, D70071, D70
Company DUNS108870254
Company NameIcad, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-866-280-2239
Emailservice@icadmed.com
Phone1-866-280-2239
Emailservice@icadmed.com
Phone1-866-280-2239
Emailservice@icadmed.com
Phone1-866-280-2239
Emailservice@icadmed.com
Phone1-866-280-2239
Emailservice@icadmed.com
Phone1-866-280-2239
Emailservice@icadmed.com
Phone1-866-280-2239
Emailservice@icadmed.com
Phone1-866-280-2239
Emailservice@icadmed.com
Phone1-866-280-2239
Emailservice@icadmed.com
Phone1-866-280-2239
Emailservice@icadmed.com
Phone1-866-280-2239
Emailservice@icadmed.com
Phone1-866-280-2239
Emailservice@icadmed.com
Phone1-866-280-2239
Emailservice@icadmed.com
Phone1-866-280-2239
Emailservice@icadmed.com
Phone1-866-280-2239
Emailservice@icadmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100858012005885 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAKSystem, X-Ray, Tomography, Computed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-25
Device Publish Date2021-05-17

On-Brand Devices [VeraLook CTC CAD]

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.