Duns Number:042356781
Device Description: FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device t FractureDetect (FX) is a computer-assisted detection and diagnosis (CAD) software device to assist clinicians in detecting fractures during the review of radiographs of the musculoskeletal system. FX is indicated for adults only.
Catalog Number
-
Brand Name
FractureDetect (FX)
Version/Model Number
1.0.0
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K193417
Product Code
QBS
Product Code Name
Radiological Computer Assisted Detection/Diagnosis Software For Fracture
Public Device Record Key
9b8bff47-11fb-45ef-9409-8b76e24a9d5a
Public Version Date
May 10, 2021
Public Version Number
2
DI Record Publish Date
April 12, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |