Rapid NCCT Stroke
FDA 510(k) K222884 · Ischemaview, Inc.
510(k) numberK222884
Submission
- Device name
- Rapid NCCT Stroke
- Applicant
- Ischemaview, Inc.
Golden, CO, US - Received
- September 22, 2022
- Decision date
- March 2, 2023
- 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 NCCT Stroke cleared by the FDA?
Rapid NCCT Stroke (K222884) received a 510(k) decision of Substantially Equivalent on March 2, 2023, 161 days after the submission was received.
What is the product code of K222884?
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.