Ischemaview, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
22
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251987Rapid Aortic MeasurementsSeptember 23, 2025
K251533Rapid Obstructive Hydrocephalus, Rapid OHSeptember 4, 2025
K252526Rapid DeltaFuseAugust 26, 2025
K251151Rapid CTA 360July 16, 2025
K243378Rapid MLSMay 28, 2025
K243350Rapid Neuro3DJanuary 22, 2025
K233582RapidApril 22, 2024
K232156Rapid ASPECTS (v3)January 19, 2024
K233512Rapid (6.0)January 16, 2024
K232436Rapid SDHOctober 25, 2023
K230074Rapid Aneurysm Triage and NotificationJuly 27, 2023
K222884Rapid NCCT StrokeMarch 2, 2023
K223396Rapid RV/LVFebruary 1, 2023
K221456Rapid ICHSeptember 12, 2022
K221248Rapid LVOMay 31, 2022
K220499Rapid PE Triage and Notification (PETN)May 17, 2022
K213165RapidFebruary 8, 2022
K200941Rapid LVOJuly 9, 2020
K200760Rapid ASPECTSJune 26, 2020
K182130iSchemaView RAPIDDecember 27, 2018