PEDRA-17F Digital Flat Panel X-ray Detector— 510(k) K180989
Substantially EquivalentRadisen, Inc.
FDA 510(k) clearance K180989 for PEDRA-17F Digital Flat Panel X-ray Detector, Substantially Equivalent on 2018-06-13. Applicant: Radisen, Inc.. Device class: 2.
Clearance details
- Applicant
- Radisen, Inc.
- 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
- Seoul, KR
Recent devices under product code MQB
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