AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4— 510(k) K231709
Substantially EquivalentRadmedix, LLC
FDA 510(k) clearance K231709 for AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4, Substantially Equivalent on 2023-07-12. Applicant: Radmedix, LLC. Device class: 2.
Clearance details
- Applicant
- Radmedix, LLC
- Product code
- Code MQB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dayton, OH, US
Recent devices under product code MQB
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