BrightHeart View Classifier— 510(k) K243684
Substantially EquivalentBrightheart
FDA 510(k) clearance K243684 for BrightHeart View Classifier, Substantially Equivalent on 2025-05-07. Applicant: Brightheart. Device class: 2.
Clearance details
- Applicant
- Brightheart
- 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
- Paris, FR
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