Ischemaview, Inc.

FDA Regulatory Profile

Ischemaview, Inc. has 0 FDA recalls, 0 inspections, 24 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Jul 13, 2026

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances24Oct 4, 2026Not statedCurrent
Inspections0Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K261085Rapid Vessel Occlusion (Rapid VO)Jul 13, 2026
K251987Rapid Aortic MeasurementsSep 23, 2025
K251533Rapid Obstructive Hydrocephalus, Rapid OHSep 4, 2025
K252526Rapid DeltaFuseAug 26, 2025
K251151Rapid CTA 360Jul 16, 2025
K243378Rapid MLSMay 28, 2025
K243350Rapid Neuro3DJan 22, 2025
K233582RapidApr 22, 2024
K232156Rapid ASPECTS (v3)Jan 19, 2024
K233512Rapid (6.0)Jan 16, 2024
K232436Rapid SDHOct 25, 2023
K230074Rapid Aneurysm Triage and NotificationJul 27, 2023
K222884Rapid NCCT StrokeMar 2, 2023
K223396Rapid RV/LVFeb 1, 2023
K221456Rapid ICHSep 12, 2022
K221248Rapid LVOMay 31, 2022
K220499Rapid PE Triage and Notification (PETN)May 17, 2022
K213165RapidFeb 8, 2022
K200941Rapid LVOJul 9, 2020
K200760Rapid ASPECTSJun 26, 2020