Omni Legend

K241665

GE Medical Systems Israel, Functional Imaging · cleared 2024-08-08 · product code KPS · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.6)
“GE HealthCare's subject Omni Legend device, same as the unmodified predicate device, is a hybrid digital PET/CT diagnostic imaging system combining a GEHC Positron Emission Tomography (PET) System and a current production diagnostic GEHC Computed Tomography (CT) System. The proposed Omni Legend is a conventional, general-purpose PET/CT system using existing technological characteristics with identical Intended Use and Indications for Use as its predicate. Omni Legend's major components include PET gantry / detector, GEHC commercially available Revolution Maxima CT system (K192686), patient table, operator console / workspace, computing hardware, power distribution unit, system software, and image reconstruction software. The operator console and system software control image acquisition and reconstruction, image display and post processing analysis, protocol and patient management, CT dose display, networking, filming, etc. Image Reconstruction / Processing: Iterative Image Reconstruction, including Precision DL (K223212). PET Digital Gating (DDG) also known as MotionFree (K180318) Enhanced AC option”
AlgorithmIterative Image Reconstruction, including Precision DL
source quote (p.8)
“Iterative Image Reconstruction, including Precision DL (K223212). PET Digital Gating (DDG) also known as MotionFree (K180318) Enhanced AC option”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated

endpoints: System Sensitivity; Noise Equivalent Count Rate (NECR); Contrast Recovery and Contrast to Noise Ratio; Spatial Resolution; Quantitation; Dose / Time Reduction (Acquisition and Image Quality); Design for Scalability; qualitative and quantitative evaluation of PET images corrected with Enhanced AC, including demonstration of improvement in lesion quantitation

standards: IEC 60601-1, IEC 60601-1-2, 60601-1-3, 60601-2-44, NEMA NU 2-2018, ISO 13485

Reader study (MRMC)

sample size not stated

endpoints: assessment of overall diagnostic image quality using a Likert Scale; ability of Enhanced AC to correct artifacts

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 matches this device's applicant.

    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 matches this device's applicant.

    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 MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 9, Andrey Sakharov Haifa Israel) — same firm and product code, not necessarily this device · 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 easily identified in transaxial slices on the acquisition console (both corrected and non-corrected for attenuation).

    recall event 98269 (openFDA)

  • Recalling firm matches this device's applicant (GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel) — same firm and product code, not necessarily this device · initiated 2025-12-10

    GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.

    recall event 98133 (openFDA)

  • Recalling firm matches this device's applicant (GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel) — same firm and product code, not necessarily this device · initiated 2025-12-10

    GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.

    recall event 98133 (openFDA)

  • Recalling firm matches this device's applicant (GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 9, Andrey Sakharov Haifa Israel) — same firm and product code, not necessarily this device · initiated 2025-09-12

    GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

    recall event 97647 (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/K241665