INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN— 510(k) K111098
Substantially EquivalentImaging Dynamics Company , Ltd.
FDA 510(k) clearance K111098 for INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN, Substantially Equivalent on 2011-05-27. Applicant: Imaging Dynamics Company , Ltd.. Device class: 2.
Clearance details
- Applicant
- Imaging Dynamics Company , Ltd.
- 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
- Special
- Location
- Naples, FL, US
Recent devices under product code MQB
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