IMAGEN3D— 510(k) K122241
Substantially EquivalentCardiovascular Imaging Technologies
FDA 510(k) clearance K122241 for IMAGEN3D, Substantially Equivalent on 2012-10-24. Applicant: Cardiovascular Imaging Technologies. Device class: 2.
Clearance details
- Applicant
- Cardiovascular Imaging Technologies
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lenexa, KS, US
Recent devices under product code KPS
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