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FDA 510(k), K193417, FractureDetect (FX)
FDA 510(k), K193417, FractureDetect (FX)
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510(K) Number: K193417
Device Name: FractureDetect (FX)
Manufacturer: Imagen Technologies, Inc.
Device Classification Name: radiological computer assisted detection/diagnosis software for fracture
Regulation Number: 892.2090
Classification Product Code: QBS
Date Received: 12/09/2019
Decision Date: 07/30/2020
Regulation Medical Specialty: Radiology
Device Name: FractureDetect (FX)
Manufacturer: Imagen Technologies, Inc.
Device Classification Name: radiological computer assisted detection/diagnosis software for fracture
Regulation Number: 892.2090
Classification Product Code: QBS
Date Received: 12/09/2019
Decision Date: 07/30/2020
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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