FDA.reportPublic FDA data

510(k) K222884

Device
Rapid NCCT Stroke
Applicant
Ischemaview, Inc.
510(k) number
K222884
Product code
QAS
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-02
Date received
2022-09-22
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

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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510(k), Device, Applicant table
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K251533Rapid Obstructive Hydrocephalus, Rapid OHIschemaview, Inc.2025-09-04
K251983Brainomix 360 Triage StrokeBrainomix Limited2025-08-26
K251590Methinks CTA StrokeMethinks Software, S.L2025-08-20
K251151Rapid CTA 360Ischemaview2025-07-16