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.”

AlgorithmAutomatic Calcium Scoring Evaluation algorithm that assigns probability of calcification based on location, density, shape, and properties, and labels calcifications to coronary arteries.

source quote (p.5)

“Since the last 510(k) clearance of the predicate device (syngo.CT Calcium Scoring SOMARIS/8 VB40, K192763, clearance date 12/17/2019) the algorithm to precompute the calcium score has been enhanced and extended. In the subject device, the CaScoring algorithm was extended to label coronary calcifications as belonging to either the left main, left anterior descending, left circumflex or right coronary artery. 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)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

sample size not stated

endpoints: adequate and acceptable performance of the automatic scoring algorithm was found for the total Agatston-equivalent score and the classification into the corresponding Agatston score categories; All pre-specified acceptability criteria were passed

Reader study (MRMC)

sample size not stated · 1 site(s)

endpoints: all prespecified acceptability thresholds were met by the results of this study; overall statistics on the performance of the automatic scoring algorithm demonstrate a good comparability with the bench test population; No statistically relevant difference between the performance of the three individual readers compared to their consensus, and the algorithm compared to the consensus was found

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

recalls in product code, 24mo

192

MAUDE reports in code, 12mo

-22%

vs code's own 3-yr baseline

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.

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).