pixium 4343RCE— 510(k) K170113
Substantially EquivalentPhilips Medical Systems Dmc GmbH
FDA 510(k) clearance K170113 for pixium 4343RCE, Substantially Equivalent on 2017-02-09. Applicant: Philips Medical Systems Dmc GmbH. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems Dmc GmbH
- 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
- Hamburg, DE
Recent devices under product code MQB
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