syngo.CT CaScoring
K192763Siemens Medical Solutions USA, Inc. · cleared 2019-12-17 · product code JAK · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“syngo.CT CaScoring is an image analysis software package for evaluating CT data sets.”
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.”
source quote (p.6)
“The automated calcium scoring algorithm which is implemented in the software version SOMARIS/8 VB40 of the subject device is equivalent to the secondary predicate device HealthCCS. The automatic calcium scoring algorithm works in the same manner as cleared with the secondary predicate device. From a functional perspective there are no differences.”
Validation studies (1)
Bench
sample size not stated
endpoints: algorithm performance; overall accuracy of the prediction of the calcium risk category
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 (1 observation)
source quote (p.7)
“An adequate overall accuracy of the prediction of the calcium risk category was found.”
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
- 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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K201034 (decision 2020-05-14) 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:K201034
- 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
- …and 5 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).