Cleared Traditional

K232436 - Rapid SDH

K232436 is the FDA 510(k) clearance for Rapid SDH by Ischemaview, Inc.. It is a Class 2 Radiology device (product code QAS) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K232436 · Ischemaview, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
72d
Days
Class 2
Risk

K232436 is an FDA 510(k) clearance for the Rapid SDH. Classified as Radiological Computer-assisted Triage And Notification Software (product code QAS), Class II - Special Controls.

Submitted by Ischemaview, Inc. (Golden, US). The FDA issued a Cleared decision on October 25, 2023 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2080 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Ischemaview, Inc. devices

Submission Details

510(k) Number K232436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2023
Decision Date October 25, 2023
Days to Decision 72 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 107d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QAS Radiological Computer-assisted Triage And Notification Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2080
Definition 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 Software-based Image Analysis But Does Not Provide Information From The Image Analysis Other Than Triage And Notification .
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - QAS Radiological Computer-assisted Triage And Notification Software

All 84
Devices cleared under the same product code (QAS) and FDA review panel - the closest regulatory comparables to K232436.
CINA-iPE
K233968 · Avicenna.Ai · Mar 2024
Brainomix 360 Triage Stroke
K232496 · Brainomix Limited · Nov 2023
BriefCase-Triage
K232751 · Aidoc Medical , Ltd. · Oct 2023
EFAI NeuroSuite CT ICH Assessment System
K231025 · Ever Fortune.Ai, Co., Ltd. · Oct 2023
Brainomix 360 Triage LVO
K231837 · Brainomix Limited · Sep 2023
Annalise Enterprise CTB Triage Trauma
K231384 · Annalise-Ai Pty , Ltd. · Sep 2023