Vereos PET/CT

K211764

Philips Medical Systems Nederland B.V. · cleared 2021-08-06 · product code KPS · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The proposed Vereos PET/CT system is an integrated diagnostic X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) system designed for a wide range of diagnostic applications. Computerized Tomography (CT) is a medical imaging technique that uses X-rays to obtain cross sectional images of the head or body. The quality of the images depends on the level and amount of X-ray energy delivered to the tissue. CT imaging displays both high-density tissue, such as bone, and soft tissue. When interpreted by a trained physician, CT images provide useful diagnostic information. Positron Emission Tomography (PET) uses radiopharmaceuticals to obtain images by measuring the internal distribution of radioactivity within organs of the body. PET technology enables the practitioner to reconstruct high-resolution, three-dimensional images of biochemical and metabolic processes of organs within the body. The proposed Vereos PET/CT System includes a modification to the currently marketed and predicate device, Vereos PET/CT (K210880). The modification is limited to the addition of an optional Adaptive reconstruction algorithm ("PET AR") to be used as an additional reconstruction method for offline reconstructions.”
AlgorithmAdaptive reconstruction algorithm ("PET AR") to be used as an additional reconstruction method for offline reconstructions. The PET AR is an Artificial Intelligence-powered reconstruction algorithm that provides low noise and improves low contrast detectability as compared to OSEM (Ordered Subsets Expectation Maximization).
source quote (p.5)
“The proposed Vereos PET/CT System includes a modification to the currently marketed and predicate device, Vereos PET/CT (K210880). The modification is limited to the addition of an optional Adaptive reconstruction algorithm ("PET AR") to be used as an additional reconstruction method for offline reconstructions. In addition, a Software patch was released which limits the use of the PET AR reconstruction protocols for the scan type it's compatible with and enables identifying the PET AR reconstructed images with visual identifier to differentiate them from regular PET results. This 510(k) submission addresses the addition of a new optional Adaptive reconstruction software application being implemented in the currently marketed and predicate device, Vereos PET/CT system (K210880). The PET AR is an Artificial Intelligence-powered reconstruction algorithm that provides low noise and improves low contrast detectability as compared to OSEM (Ordered Subsets Expectation Maximization).”
Adaptive (vs locked)Yes
source quote (p.5)
“The proposed Vereos PET/CT System includes a modification to the currently marketed and predicate device, Vereos PET/CT (K210880). The modification is limited to the addition of an optional Adaptive reconstruction algorithm ("PET AR") to be used as an additional reconstruction method for offline reconstructions.”
PCCPNo
Cybersecurity addressedYes
source quote (p.7)
“Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (issued October 2, 2014).”

Validation studies (2)

Bench

sample size not stated

endpoints: compliance with International and FDA recognized consensus standards and FDA guidance document(s); meets established design input requirements; image quality verification; risk analysis risk mitigation testing

standards: IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1: 2012, IEC 60601-1-2:2014, IEC 60601-1-3:2008+A1:2013, IEC 60601-1-6:2010 +A1: 2013, IEC 60601-2-28:2017, IEC 60601-2-44:2009/AMD1:2012 and AMD2:2016, IEC 60825-1:2014, IEC 62366-1:2015, IEC 62304:2006 + A1: 2015, ISO 10993-1:2018, ISO 14971:2007

Reader study (MRMC)

sample size not stated

endpoints: image quality evaluation

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

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/K211764