FractureDetect (FX)— 510(k) K193417
Substantially EquivalentImagen Technologies, Inc.
FDA 510(k) clearance K193417 for FractureDetect (FX), Substantially Equivalent on 2020-07-30. Applicant: Imagen Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Imagen Technologies, Inc.
- Product code
- Code QBS
- Device class
- Class 2
- Regulation
- 21 CFR 892.2090
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
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