Cleared Traditional

K232431 - syngo.CT Brain Hemorrhage

K232431 is the FDA 510(k) clearance for syngo.CT Brain Hemorrhage by Siemens Medical Solutions USA, Inc.. It is a Class 2 Radiology device (product code QAS) cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K232431 · Siemens Medical Solutions USA, Inc. · Radiology device
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Mar 2024
Decision
224d
Days
Class 2
Risk

K232431 is an FDA 510(k) clearance for the syngo.CT Brain Hemorrhage. Classified as Radiological Computer-assisted Triage And Notification Software (product code QAS), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Knoxville, US). The FDA issued a Cleared decision on March 22, 2024 after a review of 224 days - an extended review 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-to-high 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 Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K232431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2023
Decision Date March 22, 2024
Days to Decision 224 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
117d slower than avg
Panel avg: 107d · This submission: 224d
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
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