FDA.report

510(k) K250694

Device
Scaida BrainCT-ICH (v1.0)
Applicant
Mlhealth 360
510(k) number
K250694
Product code
QAS
Decision
Substantially Equivalent (SESE)
Decision date
2025-11-25
Date received
2025-03-07
Regulation
892.2080
Classification name
Radiological Computer-Assisted Triage And Notification Software
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
Kumar Surender Sinwar
Address
Unit 204, 9900 King George Blvd. Surrey CA V3T0K9 V3T0K9

FDA Registration Numbers

Source Documents

510(k) summary PDF

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