FDA.report

510(k) K231871

Device
Radify Triage
Applicant
Envisionit Deepai, Ltd.
510(k) number
K231871
Product code
QFM
Decision
Substantially Equivalent (SESE)
Decision date
2024-01-17
Date received
2023-06-26
Regulation
892.2080
Classification name
Radiological Computer-Assisted Prioritization Software For Lesions
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Jaishree Naidoo
Address
Coveham House Downside Bridge Rd. Cobham GB KT11 3EP KT11 3EP

FDA Registration Numbers

Source Documents

510(k) summary PDF

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