AccessGUDID - DEVICE: VeraLook CTC CAD (00858012005908)

GUDID

Device Identifier (DI) Information

Brand Name: VeraLook CTC CAD
Version or Model: V1.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CT-102-V-US, CT-102-V, CT-103, D70070, D70071, D70147, D70148, D70158
Company Name: Icad, Inc.

Primary DI Number: 00858012005908
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 108870254 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
40867	CT system application software	An application software program intended to add specific image processing and/or analysis capabilities to an x-ray computed tomography (CT) imaging system; it is not dedicated to radiotherapy treatment planning. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software routines or groups of routines must be combined with specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and version or upgrade number.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAK	System, X-Ray, Tomography, Computed

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091529	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4d7f83dd-75dc-4bcc-8521-267b9b5352d0
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: February 08, 2018