FDA.report

510(k) K241725

Device
Better Diagnostics Caries Assist (BDCA) Version 1.0
Applicant
Better Diagnostics AI Corp.
510(k) number
K241725
Product code
MYN
Decision
Substantially Equivalent (SESE)
Decision date
2025-03-11
Date received
2024-06-14
Regulation
892.2070
Classification name
Analyzer, Medical Image
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Rajeev Nohria
Address
29 Alcott Way Avon CT US 06001 06001

FDA Registration Numbers

Source Documents

510(k) summary PDF

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