Precision DL

K223212

GE Healthcare · cleared 2023-04-27 · product code KPS · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“Precision DL is a deep learning-based image processing method intended to enhance image quality of non-ToF PET images for clinical oncology purpose, using F-18 FDG. Precision DL may be used for patients of all ages. Precision DL is deployed within the acquisition and processing software of Omni Legend, for processing images produced using non-ToF Q.Clear image reconstruction.”
Algorithmdeep learning-based image processing
source quote (p.3)
“Precision DL is a deep learning-based image processing method intended to enhance image quality of non-ToF PET images for clinical oncology purpose, using F-18 FDG. Deep learning-based image processing trained to enhance non-ToF images to have IQ performance similar to ToF images.”
Adaptive (vs locked)No
source quote (p.6)
“Precision DL brings three deep learning models to provide users the choice between different strengths of contrast enhancement and noise reduction. The three models, Low, Medium, and High Precision DL, are trained such that the High Precision DL brings the highest contrast enhancement and lowest noise reduction, while the Low Precision DL brings the lowest contrast enhancement and highest noise reduction. Medium Precision DL brings contrast-noise tradeoff in between High and Low Precision DL.”
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Bench

n=80 cases

endpoints: Quantitation Accuracy; Contrast Recovery; Contrast-to-Noise Ratio; Lesion Detectability; Dose / Time Reduction

standards: 21CFR 820, ISO 13485

Reader study (MRMC)

sample size not stated · 2 site(s)

endpoints: overall image quality; blinded preference questions

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

34
recalls in product code, 24mo
8
MAUDE reports in code, 12mo
-72%
vs code's own 3-yr baseline
4
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code KPS (GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 9, Andrey Sakharov Haifa Israel, initiated 2025-12-24): "There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most eas" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98269

  • recall_reason_pattern

    Software/algorithm-related recall in product code KPS (GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel, initiated 2025-06-20): "Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector mo" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97193

  • recall_reason_pattern

    Software/algorithm-related recall in product code KPS (Hermes Medical Solutions AB Strandbergsgatan 16 Stockholm Sweden, initiated 2024-10-31): "Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95673

  • recall_reason_pattern

    Software/algorithm-related recall in product code KPS (Canon Medical System, USA, INC., initiated 2024-09-17): "When PET-CT system is executing reconstruction, if PET acquisition for another patient is performed (or PET reconstruction for another patient is performed from raw data processing" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95471

Recalls attributed to this device

  • Recalling firm matches this device's applicant (GE Healthcare, LLC) — same firm and product code, not necessarily this device · initiated 2021-02-07

    GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range of the planned scan under specific workflows. The issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on the Smart Console. In some cases, this may also necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation.

    recall event 87811 (openFDA)

  • Recalling firm matches this device's applicant (GE Healthcare, LLC) — same firm and product code, not necessarily this device · initiated 2021-02-07

    GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range of the planned scan under specific workflows. The issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on the Smart Console. In some cases, this may also necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation.

    recall event 87811 (openFDA)

  • Recalling firm matches this device's applicant (GE Healthcare, LLC) — same firm and product code, not necessarily this device · initiated 2021-02-07

    GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range of the planned scan under specific workflows. The issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on the Smart Console. In some cases, this may also necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation.

    recall event 87811 (openFDA)

  • Recalling firm matches this device's applicant (GE Healthcare, LLC) — same firm and product code, not necessarily this device · initiated 2020-12-10

    GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.

    recall event 87023 (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/K223212