Syngo.CT CaScoring

K201034

Siemens Medical Solutions USA, Inc. · cleared 2020-05-14 · product code JAK · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“syngo.CT CaScoring is an image analysis software package for evaluating CT data sets.”
AlgorithmThe algorithm assigns a probability of a candidate being a coronary calcification based on location within the heart, density, shape and similar properties. If the probability is higher than a predefined threshold, the candidate is labelled as a calcification. Each calcification is labeled according to one of four coronary arteries it most probably belongs to.
source quote (p.6)
“Assignment of a probability of a candidate being a coronary calcification based on location within the heart, density, shape and similar properties: if the probability of a candidate is higher than a predefined threshold, the candidate is labelled as a calcification. Each calcification is labeled according to one of four coronary arteries it most probably belongs to.”
Adaptive (vs locked)No
source quote (p.7)
“Since the automatic scoring algorithm was retrained on re-annotated data as part of the vessel assignment extension, a complete performance evaluation (bench test and reader study) of the algorithm has been conducted additionally.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

sample size not stated

endpoints: total Agatston-equivalent score; classification into Agatston score categories

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

Reader study (MRMC)

sample size not stated · 1 site(s)

endpoints: comparability of automatic scoring algorithm with bench test population; comparison of individual readers to their consensus; comparison of algorithm to consensus of readers; assignment of calcifications in the bifurcation region

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 (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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

75
recalls in product code, 24mo
192
MAUDE reports in code, 12mo
-22%
vs code's own 3-yr baseline
10
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code JAK (Siemens Medical Solutions USA, Inc, initiated 2025-12-19): "To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance." Recalling firm matches this device's applicant.

    first seen 2026-07-08 · recall res_event_number:98206

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K221219 (decision 2022-05-17) from Siemens Medical Solutions USA, Inc. for a matching device line ("syngo.CT CaScoring") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K221219

  • recall_reason_pattern

    Software/algorithm-related recall in product code JAK (GE Medical Systems, LLC, initiated 2026-03-26): "GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with " Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98738

  • recall_reason_pattern

    Software/algorithm-related recall in product code JAK (PHILIPS MEDICAL SYSTEMS, initiated 2026-03-07): "Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98588

  • recall_reason_pattern

    Software/algorithm-related recall in product code JAK (PHILIPS MEDICAL SYSTEMS, initiated 2025-09-25): "Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axia" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97699

  • recall_reason_pattern

    Software/algorithm-related recall in product code JAK (Philips North America Llc, initiated 2025-05-29): "Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional " Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97010

  • …and 4 more.

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc) — same firm and product code, not necessarily this device · initiated 2025-12-19

    To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

    recall event 98206 (openFDA)

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc) — same firm and product code, not necessarily this device · initiated 2025-12-19

    To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

    recall event 98206 (openFDA)

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc) — same firm and product code, not necessarily this device · initiated 2025-12-19

    To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

    recall event 98206 (openFDA)

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc) — same firm and product code, not necessarily this device · initiated 2025-12-19

    To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

    recall event 98206 (openFDA)

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/K201034