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)
“artificial intelligence learning algorithms”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

n=600 cases · 5 site(s)

endpoints: Sensitivity; Specificity

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 89.3%-95.2%
source quote (p.6)
“Sensitivity was observed to be 92.8% (95% CI: 89.3%-95.2%).”
specificity94.5CI 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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K203260