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K233650

Siemens Medical Solutions USA, Inc. · cleared 2024-03-26 · product code JAK · Radiology

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.7)
“This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.”
AlgorithmIterative Reconstruction, Cardiac Stack Artefact Correction (SAC) reconstruction, AI-based needle tip detection
source quote (p.9)
“Iterative Reconstruction – Support of various iterative reconstruction principles. The bench tests evaluate the performance of ZeeFree reconstruction. Tests were performed to ensure clinical usability of the myNeedle Guide needle detection algorithm.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.39)
“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. Cybersecurity information in accordance with guidance document "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" issued on September 27, 2023 is included within this submission.”

Validation studies (1)

Bench

sample size not stated

endpoints: accuracy of FAST Isocentering; accuracy of FAST Range; accuracy of FAST Direction; reduction of artefacts; no new artefacts introduced; equivalent image quality in quantitative standard physics phantom-based measurements (noise, homogeneity, high-contrast resolution, slice thickness, CNR); accuracy of automatic needle detection algorithm; reduction of necessary user interactions

standards: NEMA PS 3.1 - 3.20 2022d, 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 2.1 2013-04, 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, ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021], 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, IEC 60601-1:2005+A1:2012+A2:2020, IEC/ISO 17050-1, IEC/ISO 17050-2

Reported performance (1 observation)

detection_rateas written: “needle-tip detection rate”90.76
source quote (p.34)
“It has been shown that the algorithm was able to consistently detect needle-tips over a wide variety of scans in 90.76% of cases.”

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) K253574 (decision 2026-03-20) from Siemens Medical Solutions USA, Inc. for a matching device line ("SOMATOM X.cite; SOMATOM X.ceed") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K253574

  • 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/K233650