syngo.CT CaScoring
K221219Siemens Medical Solutions USA, Inc. · cleared 2022-05-17 · 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.5)
“Since the last 510(k) clearance of the predicate device (syngo.CT Calcium Scoring SOMARIS/8 VB50, K201034, clearance date 05/14/2020) the algorithm to precompute the calcium score has been enhanced. In the subject device, the CaScoring algorithm was re-trained on a larger database.”
Validation studies (2)
Bench
sample size not stated
endpoints: test the ability of the included features of the subject device
standards: Digital Imaging and Communications in Medicine (DICOM) Set; PS 3.1 – 3.20, Medical Device Software -Software Life Cycle Processes; 62304:2015-06 (Edition 1.1), Medical devices – Application of risk management to medical devices; 14971 Third Edition 2019-12, Medical devices - Part 1: Application of usability engineering to medical devices IEC 62366-1:2015+AMD1:2020, Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements 15223-1:2016
Bench
sample size not stated
endpoints: total Agatston-equivalent score; classification into the corresponding Agatston score categories
standards: Digital Imaging and Communications in Medicine (DICOM) Set; PS 3.1 – 3.20, Medical Device Software -Software Life Cycle Processes; 62304:2015-06 (Edition 1.1), Medical devices – Application of risk management to medical devices; 14971 Third Edition 2019-12, Medical devices - Part 1: Application of usability engineering to medical devices IEC 62366-1:2015+AMD1:2020, Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements 15223-1:2016
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
- 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
- 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
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (, initiated 2025-05-23): "Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:96967
- …and 3 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).