Vereos PET/CT
K211764Philips Medical Systems Nederland B.V. · cleared 2021-08-06 · product code KPS · Radiology
Premarket evidence — what FDA accepted
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. 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.6)
“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.”
source quote (p.7)
“Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (issued October 2, 2014).”
Validation studies (1)
Reader study (MRMC)
sample size not stated
endpoints: image quality
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
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 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). 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).