Duns Number:063962130
Device Description: Computer aided detection system of suspicious lesions in automated breast ultrasound image Computer aided detection system of suspicious lesions in automated breast ultrasound images.
Catalog Number
-
Brand Name
QVCAD System
Version/Model Number
3.4.4
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P150043,P150043
Product Code
MYN
Product Code Name
Analyzer, Medical Image
Public Device Record Key
d5da750e-d5dd-4272-9d4e-8d724cef20be
Public Version Date
October 14, 2022
Public Version Number
1
DI Record Publish Date
October 06, 2022
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |