SOMATOM X.cite; SOMATOM X.ceed

K253574

Siemens Medical Solutions USA, Inc. · cleared 2026-03-20 · product code JAK · Radiology

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.4)
“This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of X-ray transmission data.”
AlgorithmThe device includes retrained FAST 3D Camera algorithms, HD FoV 5.0 algorithm for extended field of view reconstruction, FAST Planning algorithm, ZeeFree RT reconstruction, and DirectDensity algorithm for calculating stopping-power ratio. It also uses iterative reconstruction methods like ADMIRE, iMAR, and SAFIRE.
source quote (p.11)
“With software version syngo CT VB20, retrained FAST 3D Camera algorithms, collision indication, and Centerline/Grid Overlay are introduced. The bench test contains a detailed description and evaluation of the new HD FoV 5. 0 algorithm for extended field of view reconstruction. Objective of the test is to assess the fraction (percentage) of ranges calculated by the FAST Planning algorithm that are correct and can be applied without change. The bench test evaluates the performance of the ZeeFree RT reconstruction. The test results show for the iBHC variants Artificial120, eDDensity, mDDensity and StoppingPowerRatio a reduced dependence on tube voltage and filtration compared to the corresponding quantitative kernel (Qr) with iBHC Bone for non-water-like tissues, such as adipose and bone. Iterative Reconstruction Methods: ADMIRE, iMAR, SAFIRE.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.34)
“Siemens conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient.”

Validation studies (2)

Bench

sample size not stated

endpoints: accuracy; calculation time; CT values and noise levels; geometrical distortions; position or shape of a dynamic thorax phantom; stack artefact corrected images; new artefacts

standards: NEMA PS 3.1-3.20 2023e, NEMA XR 25-2019, NEMA XR 28-2018, IEC 61223-3-5 Edition 2.0 2019-09, IEC 61223-2-6 Second Edition 2006-11, IEC 60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION, IEC 60601-2-44 Edition 3.2: 2016, ANSI AAMI ISO 14971: 2019, ISO 14971 Third Edition 2019-12, ANSI AAMI IEC 62304:2006/A1:2016, IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION, ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021], ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021], IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION, ANSI AAMI IEC 62366-1:2015+AMD1:2020 (Consolidated Text), IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION, IEC 60825-1 Edition 2.0 2007-03, IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION, IEC 60601-2-28 Edition 3.0 2017-06, IEC 62563-1 Edition 1.2 2021-07 CONSOLIDATED VERSION

Reader study (MRMC)

n=30 patients

endpoints: as safe and effective as the HD FoV 4. 0 algorithm; successfully be applied to 4D respiratory-gated sequence images; enables the optional reconstruction of stack artefact corrected images; does not introduce relevant new artefacts

standards: NEMA PS 3.1-3.20 2023e, NEMA XR 25-2019, NEMA XR 28-2018, IEC 61223-3-5 Edition 2.0 2019-09, IEC 61223-2-6 Second Edition 2006-11, IEC 60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION, IEC 60601-2-44 Edition 3.2: 2016, ANSI AAMI ISO 14971: 2019, ISO 14971 Third Edition 2019-12, ANSI AAMI IEC 62304:2006/A1:2016, IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION, ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021], ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021], IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION, ANSI AAMI IEC 62366-1:2015+AMD1:2020 (Consolidated Text), IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION, IEC 60825-1 Edition 2.0 2007-03, IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION, IEC 60601-2-28 Edition 3.0 2017-06, IEC 62563-1 Edition 1.2 2021-07 CONSOLIDATED VERSION

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
9
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

  • 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.

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/K253574