Medical Device Manufacturer · US , Irvine , CA

Ischemaview, Inc. - FDA 510(k) Cleared Devices

23 submissions · 23 cleared · Since 2013

Recent clearances: Rapid ICH (v4.0), Rapid Platform (R6.7), Rapid Aortic Measurements

View 23 510(k) Devices ↓

Total

Cleared

Denied

Ischemaview, Inc. has 23 FDA 510(k) cleared radiology devices. Based in Irvine, US.

Latest FDA clearance: Oct 2026. Active since 2013.

Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.

Ischemaview, Inc. is one of 25959 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Ischemaview, Inc.

23 devices

1-12 of 23

Rapid Platform (R6.7)

K261368 · QIH

Radiology · 147d

Cleared Sep 23, 2025

Rapid Aortic Measurements

K251987 · QIH

Radiology · 88d

Cleared Sep 04, 2025

Rapid Obstructive Hydrocephalus, Rapid OH

Rapid Aneurysm Triage and Notification

K230074 · QFM

Radiology · 198d

Ischemaview, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Ischemaview, Inc.

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