Better Diagnostics Caries Assist (BDCA) Version 1.0— 510(k) K241725
Substantially EquivalentBetter Diagnostics AI Corp.
FDA 510(k) clearance K241725 for Better Diagnostics Caries Assist (BDCA) Version 1.0, Substantially Equivalent on 2025-03-11. Applicant: Better Diagnostics AI Corp.. Device class: 2.
Clearance details
- Applicant
- Better Diagnostics AI Corp.
- Product code
- Code MYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.2070
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Avon, CT, US
Recent devices under product code MYN
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