Deep Learning Image Reconstruction
K213999GE Medical Systems, LLC. · cleared 2022-02-18 · product code JAK · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“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.”
source quote (p.6)
“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.”
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); 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; Pediatric Phantom IQ Performance Evaluation; Low Dose Lung Cancer Screening Protocol IQ Performance Evaluation
standards: 21CFR 820, ISO 13485
Reader study (MRMC)
n=40 cases
endpoints: image quality related to diagnostic use; image noise texture; image sharpness; image noise texture homogeneity
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 (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
- 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 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 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).