Better Diagnostics Caries Assist (BDCA) Version 1.0
FDA 510(k) clearance K241725 · decided 2025-03-11
Clearance details
- K-number
- K241725
- Device name
- Better Diagnostics Caries Assist (BDCA) Version 1.0
- Applicant
- Better Diagnostics AI Corp.
- Decision
- Substantially Equivalent
- Date received
- 2024-06-14
- Decision date
- 2025-03-11
- Days to decision
- 270 days
- Clearance type
- Traditional
- Product code
- MYN
- Device class
- 2
- Regulation number
- 892.2070
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Avon, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.