InVision Precision Cardiac Amyloid— 510(k) K243866
Substantially EquivalentInVision Medical Technology Corporation
FDA 510(k) clearance K243866 for InVision Precision Cardiac Amyloid, Substantially Equivalent on 2025-05-21. Applicant: InVision Medical Technology Corporation. Device class: 2.
Clearance details
- Applicant
- InVision Medical Technology Corporation
- Product code
- Code SDJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.2200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Angeles, CA, US
Recent devices under product code SDJ
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