FDA.report

510(k) K221248

Device
Rapid LVO
Applicant
Ischemaview, Inc.
510(k) number
K221248
Product code
QAS
Decision
Substantially Equivalent (SESE)
Decision date
2022-05-31
Date received
2022-05-02
Regulation
892.2080
Classification name
Radiological Computer-Assisted Triage And Notification Software
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
James Rosa
Address
1120 Washington Ave. Suite 200 Golden CO US 80401 80401

FDA Registration Numbers

Source Documents

510(k) summary PDF

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