DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)— 510(k) K161368
Substantially EquivalentAgfa Healthcare N.V.
FDA 510(k) clearance K161368 for DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s), Substantially Equivalent on 2016-09-22. Applicant: Agfa Healthcare N.V.. Device class: 2.
Clearance details
- Applicant
- Agfa Healthcare N.V.
- 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
- Mortsel, BE
Recent devices under product code MQB
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