Flat Panel Detector— 510(k) K201591
Substantially EquivalentKa Imaging, Inc.
FDA 510(k) clearance K201591 for Flat Panel Detector, Substantially Equivalent on 2020-09-03. Applicant: Ka Imaging, Inc.. Device class: 2.
Clearance details
- Applicant
- Ka Imaging, Inc.
- Product code
- Product 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
- Waterloo, CA
Recent devices under product code MQB
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