Biograph Vision.X and Biograph Vision.X Edge
K231833Siemens Medical Solutions USA, Inc. · cleared 2023-07-13 · product code KPS · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“The Biograph Vision.X and Biograph Vision.X Edge PET/CT systems are combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanners.”
source quote (p.8)
“Cybersecurity information in accordance with FDA Guidance documents has been provided. The Biograph Vision.X and Biograph Vision.X Edge software has specific cybersecurity controls to prevent unauthorized access, modifications, misuse or denial of use. Additionally, controls are enabled to prevent the unauthorized use of information that is stored, accessed or transferred between the Biograph Vision.X and Biograph Vision.X Edge systems and external devices.”
Validation studies (1)
Bench
sample size not stated
endpoints: Transverse Resolution FWHM @ 1 cm; Transverse Resolution FWHM @ 10 cm; Transverse Resolution FWHM @ 20 cm; Axial Resolution FWHM @ 1 cm; Axial Resolution FWHM @ 10 cm; Axial Resolution FWHM @ 20 cm; Sensitivity @435 keV LLD; Count Rate peak NECR; Count Rate peak trues; Scatter Fraction at peak NECR; Co-Registration Accuracy; Time of Flight Resolution at 5.3kBq/cc; 10mm sphere (Contrast / Background Variability); 13mm sphere (Contrast / Background Variability); 17mm sphere (Contrast / Background Variability); 22mm sphere (Contrast / Background Variability); 28mm sphere (Contrast / Background Variability); 37mm sphere (Contrast / Background Variability); Lung Residual Error
standards: ISO 14971, IEC 60601-1 series, 21 CFR 1020.30, 21 CFR 1020.33, IEC 60601-1: 2005+ A1:2012, IEC 60601-1-2: 2014, IEC 60601-1-3: 2008 + A1:2013, IEC 60601-1-6:2010 +A1:2013 + A2:2020, IEC 60601-2-28:2017, IEC 60601-2-44: 2016, IEC 60825-1: 2007, IEC 62366-1: 2015 +A1:2020, ISO 10993-1: 2018, IEC 61223-2-6:2006, IEC 61223-3-5:2019, NEMA NU 2: 2018, NEMA XR 25: 2019, NEMA PS3.1-3.20 2021e, IEC 62304:2015, ISO 14971:2019, ISO 13485:2015
Reported performance (2 observations)
source quote (p.7)
“Sensitivity @435 keV LLD Pass ≥ 15 cps/kBq”
source quote (p.7)
“Co-Registration Accuracy Pass ≤ 5 mm”
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).