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Ischemaview, Inc.

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

Total Devices20
Categories5
Latest Approval2025-09-23
TypeNumberDevice NameCodeDate
510(k) K251987 Rapid Aortic Measurements QIH 2025-09-23 View
510(k) K251533 Rapid Obstructive Hydrocephalus, Rapid OH QAS 2025-09-04 View
510(k) K252526 Rapid DeltaFuse LLZ 2025-08-26 View
510(k) K243378 Rapid MLS QIH 2025-05-28 View
510(k) K243350 Rapid Neuro3D QIH 2025-01-22 View
510(k) K233582 Rapid LLZ 2024-04-22 View
510(k) K232156 Rapid ASPECTS (v3) POK 2024-01-19 View
510(k) K233512 Rapid (6.0) QIH 2024-01-16 View
510(k) K232436 Rapid SDH QAS 2023-10-25 View
510(k) K230074 Rapid Aneurysm Triage and Notification QFM 2023-07-27 View
510(k) K222884 Rapid NCCT Stroke QAS 2023-03-02 View
510(k) K223396 Rapid RV/LV QIH 2023-02-01 View
510(k) K221456 Rapid ICH QAS 2022-09-12 View
510(k) K221248 Rapid LVO QAS 2022-05-31 View
510(k) K220499 Rapid PE Triage and Notification (PETN) QAS 2022-05-17 View
510(k) K213165 Rapid LLZ 2022-02-08 View
510(k) K200941 Rapid LVO QAS 2020-07-09 View
510(k) K200760 Rapid ASPECTS POK 2020-06-26 View
510(k) K182130 iSchemaView RAPID LLZ 2018-12-27 View
510(k) K172477 iSchemaView RAPID LLZ 2018-04-19 View