Hi-D Imaging 4TAVR— 510(k) K241984
Substantially EquivalentHi-D Imaging AG
FDA 510(k) clearance K241984 for Hi-D Imaging 4TAVR, Substantially Equivalent on 2025-04-02. Applicant: Hi-D Imaging AG.
Clearance details
- Applicant
- Hi-D Imaging AG
- Product code
- Code QIH
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Winterthur, CH
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