FDA.report

510(k) K251533

Device
Rapid Obstructive Hydrocephalus, Rapid OH
Applicant
Ischemaview, Inc.
510(k) number
K251533
Product code
QAS
Decision
Substantially Equivalent (SESE)
Decision date
2025-09-04
Date received
2025-05-19
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
N

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

Other 510(k) Records For Product Code QAS

510(k)DeviceApplicantDecision date
K261317BriefCase-TriageAidoc Medical , Ltd.2026-05-14
K253163EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)Ever Fortune.Ai, Co., Ltd.2026-04-22
K252421JLK-NCCTJLK, Inc.2026-03-24
K253818Annalise EnterpriseHarrison-AI Medical Pty, Ltd.2026-03-03
K253578BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation deviceAidoc Medical , Ltd.2026-02-26
K251195BriefCase-TriageAidoc Medical , Ltd.2026-01-27
K252970BriefCase-Triage: CARE Multi-triage CT BodyAidoc Medical , Ltd.2026-01-07
K250694Scaida BrainCT-ICH (v1.0)Mlhealth 3602025-11-25
K252366a2z-Unified-TriageA2z Radiology Ai, Inc.2025-11-24
K253265BriefCase-TriageAidoc Medical , Ltd.2025-11-06
K251610qER-CTA (v1.0)Qure.Ai Technologies2025-09-08
K251983Brainomix 360 Triage StrokeBrainomix Limited2025-08-26
K251590Methinks CTA StrokeMethinks Software, S.L2025-08-20
K251151Rapid CTA 360Ischemaview2025-07-16
K250685Methinks NCCT StrokeMethinks Software, S.L2025-06-16