Rapid ICH
FDA 510(k) K193087 · Ischemaview Incorporated
510(k) numberK193087
Submission
- Device name
- Rapid ICH
- Applicant
- Ischemaview Incorporated
Golden, CO, US - Received
- November 6, 2019
- Decision date
- March 31, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QAS – Radiological Computer-Assisted Triage And Notification Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2080
- Specialty
- Radiology
Radiological computer-assisted triage and notification software is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on…
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Questions and answers
When was Rapid ICH cleared by the FDA?
Rapid ICH (K193087) received a 510(k) decision of Substantially Equivalent on March 31, 2020, 146 days after the submission was received.
What is the product code of K193087?
The FDA product code is QAS – Radiological Computer-Assisted Triage And Notification Software, a Class II (moderate risk) device regulated under 21 CFR 892.2080.