Duns Number:108870254
Device Description: VeraLook® CTC CAD Software is intended to automatically detect potential polyps in CT Colo 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.
Catalog Number
CT-102-V-US, CT-102-V, CT-103, D70070, D70071, D70147, D70148, D70158
Brand Name
VeraLook CTC CAD
Version/Model Number
V1.0
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K091529
Product Code
JAK
Product Code Name
System, X-Ray, Tomography, Computed
Public Device Record Key
c44f142f-cd13-42bb-8ca2-972a3e2fcfaa
Public Version Date
May 25, 2021
Public Version Number
1
DI Record Publish Date
May 17, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 87 |