TeraRecon Cardiovascular.Calcification.CT— 510(k) K250288
Substantially EquivalentTerarecon,Inc.
FDA 510(k) clearance K250288 for TeraRecon Cardiovascular.Calcification.CT, Substantially Equivalent on 2025-10-23. Applicant: Terarecon,Inc.. Device class: 2.
Clearance details
- Applicant
- Terarecon,Inc.
- Product code
- Code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Durham, NC, US
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