True Definition DL

K253686

Ge Healthcare Japan Corporation · cleared 2026-03-23 · product code JAK · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“True Definition DL is a deep learning based CT reconstruction method intended for high contrast spatial resolution enhancement for bone and lung imaging.”
Algorithmdeep learning based CT reconstruction method
source quote (p.4)
“True Definition DL is a deep learning based CT reconstruction method intended for high contrast spatial resolution enhancement for bone and lung imaging.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated

endpoints: overall image quality; substantially equivalent performance

standards: 21CFR 820, ISO 13485

Reader study (MRMC)

sample size not stated

endpoints: diagnostic value by improving high contrast spatial resolution in routine bone (including inner ears and spines) and lung exams; improves confidence in the assessment of high contrast structures in in these types of images; images enhanced by the subject device do not present algorithm-induced artifacts or enhancements not supported by underlying anatomies

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 (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 (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 is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98206

  • 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); 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/K253686