Biograph Vision, Biograph mCT Family of PET/CTs
K193248Siemens Medical Solutions USA, Inc · cleared 2020-02-14 · product code KPS · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“The Biograph Vision and Biograph mCT PET/CT systems are combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanners. These systems are designed for whole body oncology, neurology and cardiology examinations. The Biograph Vision and Biograph mCT systems provide registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system (PET and CT). Modifications include, corrections to software anomalies and addition of new software features, including: OncoFreeze AI (Data Driven Gating), FlowMotion AI (PET FAST Planning), FAST PET Workflow, Updates to HD FoV, Updates to PET DICOM dose Report, Whole Body Scatter Correction (for Biograph Vision)”
source quote (p.6)
“Modifications include, corrections to software anomalies and addition of new software features, including: OncoFreeze AI (Data Driven Gating), FlowMotion AI (PET FAST Planning), FAST PET Workflow, Updates to HD FoV, Updates to PET DICOM dose Report, Whole Body Scatter Correction (for Biograph Vision)”
source quote (p.11)
“Cybersecurity information in accordance with FDA Guidance documents issued October 2, 2014 has been provided. The Biograph Vision and Biograph mCT 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, Biograph mCT and external devices.”
Validation studies (5)
Bench
sample size not stated
Bench
sample size not stated
standards: NEMA NU2-2018
Bench
sample size not stated
endpoints: change in SUVmax; change in SUVmean; volume measurement
Bench
sample size not stated
endpoints: accuracy with which FlowMotion AI correctly defines the bed ranges; Successful identification of all ranges
Bench
sample size not stated
endpoints: evaluate ROI's using single bed scatter compared to whole body scatter
Reported performance (5 observations)
source quote (p.8)
“≥ 8.0 cps/kBq”
source quote (p.8)
“≥ 15.0 cps/kBq”
source quote (p.9)
“≥ 5.0 cps/kBq”
source quote (p.9)
“≥ 9.4 cps/kBq”
source quote (p.8)
“≤ 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).