XPLORER 1600— 510(k) K042041
Substantially EquivalentImaging Dynamics Company Limited
FDA 510(k) clearance K042041 for XPLORER 1600, Substantially Equivalent on 2004-09-17. Applicant: Imaging Dynamics Company Limited. Device class: 2.
Clearance details
- Applicant
- Imaging Dynamics Company Limited
- 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
- Calgary, CA
Recent devices under product code MQB
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