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Ischemaview, Inc.

FDA 510(k) & PMA Approved Devices — 20 products

Total Devices20
Categories5
Latest FDA decision2025-09-23
TypeNumberDevice NameCodeDateActions
510(k) K251987 Rapid Aortic MeasurementsQIH2025-09-23 View
510(k) K251533 Rapid Obstructive Hydrocephalus, Rapid OHQAS2025-09-04 View
510(k) K252526 Rapid DeltaFuseLLZ2025-08-26 View
510(k) K243378 Rapid MLSQIH2025-05-28 View
510(k) K243350 Rapid Neuro3DQIH2025-01-22 View
510(k) K233582 RapidLLZ2024-04-22 View
510(k) K232156 Rapid ASPECTS (v3)POK2024-01-19 View
510(k) K233512 Rapid (6.0)QIH2024-01-16 View
510(k) K232436 Rapid SDHQAS2023-10-25 View
510(k) K230074 Rapid Aneurysm Triage and NotificationQFM2023-07-27 View
510(k) K222884 Rapid NCCT StrokeQAS2023-03-02 View
510(k) K223396 Rapid RV/LVQIH2023-02-01 View
510(k) K221456 Rapid ICHQAS2022-09-12 View
510(k) K221248 Rapid LVOQAS2022-05-31 View
510(k) K220499 Rapid PE Triage and Notification (PETN)QAS2022-05-17 View
510(k) K213165 RapidLLZ2022-02-08 View
510(k) K200941 Rapid LVOQAS2020-07-09 View
510(k) K200760 Rapid ASPECTSPOK2020-06-26 View
510(k) K182130 iSchemaView RAPIDLLZ2018-12-27 View
510(k) K172477 iSchemaView RAPIDLLZ2018-04-19 View