FDA.report

510(k) K223754

Device
BraveCX
Applicant
Bering, Ltd.
510(k) number
K223754
Product code
QFM
Decision
Substantially Equivalent (SESE)
Decision date
2023-11-09
Date received
2022-12-15
Regulation
892.2080
Classification name
Radiological Computer-Assisted Prioritization Software For Lesions
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Drozdov Ignat
Address
54 Portland Pl., 2nd Floor London GB W1B 1DY W1B 1DY

FDA Registration Numbers

Source Documents

510(k) summary PDF

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