Company profile

iSchemaView, Inc.

iSchemaView, Inc. has 15 AI-enabled medical devices on the FDA list. The first decision was on December 27, 2018 and the most recent on September 23, 2025 (Rapid Aortic Measurements). Its most common review panel is Radiology (15 devices).

15AI devices

2018First decision

2025Latest decision

1Specialties

Per year

201820202022202320242025

iSchemaView, Inc. AI devices per year: 2018 1, 2020 2, 2022 3, 2023 3, 2024 2, 2025 4

By specialty

Radiology15

Related guides

Top radiology devices

Timeline

September 23, 2025 · 510(k) K251987Rapid Aortic Measurements · Radiology · QIH
September 4, 2025 · 510(k) K251533Rapid Obstructive Hydrocephalus, Rapid OH · Radiology · QAS
May 28, 2025 · 510(k) K243378Rapid MLS · Radiology · QIH
January 22, 2025 · 510(k) K243350Rapid Neuro3D · Radiology · QIH
January 19, 2024 · 510(k) K232156Rapid ASPECTS (v3) · Radiology · POK
January 16, 2024 · 510(k) K233512Rapid (6.0) · Radiology · QIH
October 25, 2023 · 510(k) K232436Rapid SDH · Radiology · QAS
July 27, 2023 · 510(k) K230074Rapid Aneurysm Triage and Notification · Radiology · QFM
March 2, 2023 · 510(k) K222884Rapid NCCT Stroke · Radiology · QAS
September 12, 2022 · 510(k) K221456Rapid ICH · Radiology · QAS
May 31, 2022 · 510(k) K221248Rapid LVO · Radiology · QAS
May 17, 2022 · 510(k) K220499Rapid PE Triage and Notification (PETN) · Radiology · QAS
July 9, 2020 · 510(k) K200941Rapid LVO · Radiology · QAS
June 26, 2020 · 510(k) K200760Rapid ASPECTS · Radiology · POK
December 27, 2018 · 510(k) K182130iSchemaView RAPID · Radiology · LLZ