syngo.CT Brain Hemorrhage

K203260

Siemens Medical Solutions USA, Inc. · cleared 2022-01-28 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“The subject device syngo.CT Brain Hemorrhage is an image processing software that utilizes artificial intelligence learning algorithms to support qualified clinicians in analysis and prioritization of non-contrast head CT DICOM images by algorithmically identifying findings suspicious of acute intracranial hemorrhage.”

Algorithmartificial intelligence learning algorithms

source quote (p.5)

“The subject device syngo.CT Brain Hemorrhage is an image processing software that utilizes artificial intelligence learning algorithms to support qualified clinicians in analysis and prioritization of non-contrast head CT DICOM images by algorithmically identifying findings suspicious of acute intracranial hemorrhage.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=600 cases · 5 site(s)

endpoints: Sensitivity and specificity in processing of non-contrast head CT

standards: Digital Imaging and Communications in Medicine (DICOM) Set; PS 3.1 – 3.20, Medical Device Software -Software Life Cycle Processes; 62304:2006 (1st Edition), Medical devices - Application of risk management to medical devices; 14971 Second Edition 2007-03-01, Medical devices - Part 1: Application of usability engineering to medical devices IEC 62366-1:2015

Reported performance (2 observations)

sensitivity92.8CI 95% CI: 89.3%-95.2%

source quote (p.6)

“Sensitivity was observed to be 92.8% (95% CI: 89.3%-95.2%).”

specificity94.5CI 95% CI: 91.3%-96.5%

source quote (p.6)

“Specificity was observed to be 94.5% (95% CI: 91.3%-96.5%).”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

re_clearance
The FDA AI/ML device list shows a newer 510(k) K232431 (decision 2024-03-22) from Siemens Medical Solutions USA, Inc. for a matching device line ("syngo.CT Brain Hemorrhage") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K232431

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).