Deep Learning Image Reconstruction

K183202

GE Medical Systems, LLC. · cleared 2019-04-12 · product code JAK · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.3)
“The Deep Learning Image Reconstruction option is a deep learning based reconstruction method intended to produce cross-sectional images of the head and whole body by computer reconstruction of X-ray transmission data taken at different angles and planes, including Axial, Helical (Volumetric), and Cardiac acquisitions, for all ages.”
Algorithmdeep learning based reconstruction method using a dedicated Deep Neural Network (DNN)
source quote (p.5)
“Deep Learning Image Reconstruction is an image reconstruction method that uses a dedicated Deep Neural Network (DNN) that has been designed and trained specifically to generate CT Images to give an image appearance, as shown on axial NPS plots, similar to traditional FBP images while maintaining the performance of ASiR-V in the following areas: image noise (pixel standard deviation), low contrast detectability, high-contrast spatial resolution, and streak artifact suppression.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated

endpoints: Low Contrast Detectability (LCD); Image Noise (pixel standard deviation); High-Contrast Spatial Resolution (MTF); Streak Artifact Suppression; Spatial Resolution, longitudinal (FWHM slice sensitivity profile); Low Contrast Detectability/resolution (statistical); Noise Power Spectrum (NPS) and Standard Deviation of noise; CT Number Uniformity; CT Number Accuracy; Contrast to Noise (CNR) ratio; Artifact analysis – metal objects, unintended motion, truncation

standards: 21CFR 820, ISO 13485

Reader study (MRMC)

n=60 cases

endpoints: assessment of image quality related to diagnostic use according to a 5-point Likert Scale; image noise texture preference; image sharpness preference; image noise texture homogeneity preference; evaluation of low contrast and small lesions

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
11
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 matches this device's applicant.

    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 matches this device's applicant.

    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 matches this device's applicant.

    first seen 2026-07-08 · recall res_event_number:97699

  • recall_reason_pattern

    Software/algorithm-related recall in product code JAK (Philips Medical Systems Nederland B.V. Veenpluis, initiated 2025-02-28): "Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement." Recalling firm matches this device's applicant.

    first seen 2026-07-08 · recall res_event_number:96423

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K213999 (decision 2022-02-18) from GE Medical Systems, LLC. for a matching device line ("Deep Learning Image Reconstruction") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K213999

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K201745 (decision 2020-12-10) from GE Medical Systems, LLC for a matching device line ("Deep Learning Image Reconstruction for Gemstone Spectral Imaging") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K201745

  • …and 5 more.

Recalls attributed to this device

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · 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 certain Revolution Apex, Revolution Ascend, and Revolution CT systems.

    recall event 98738 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · 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 certain Revolution Apex, Revolution Ascend, and Revolution CT systems.

    recall event 98738 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · 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 certain Revolution Apex, Revolution Ascend, and Revolution CT systems.

    recall event 98738 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · 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 certain Revolution Apex, Revolution Ascend, and Revolution CT systems.

    recall event 98738 (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/K183202