Biograph Vision.X and Biograph Vision.X Edge

K231833

Siemens Medical Solutions USA, Inc. · cleared 2023-07-13 · product code KPS · Radiology

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.3)
“The Siemens Biograph systems are combined x-ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of physiologic and anatomic information.”
Algorithmcommand-based program used for patient management, data management, scan control, image reconstruction and image archival and evaluation
source quote (p.5)
“Biograph Vision.X and Biograph Vision.X Edge software is a command-based program used for patient management, data management, scan control, image reconstruction and image archival and evaluation.”
Adaptive (vs locked)No
source quote (p.8)
“Verification and validation of Siemens systems is performed in accordance with documented procedures, design and code reviews, test plans and specifications. Traceability of the requirements specified in the requirement specifications and functional specifications is ensured during component integration, software validation and system testing.”
PCCPNo
Cybersecurity addressedYes
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: NEMA NU2-2018, ISO 14971

Reported performance (1 observation)

accuracyas written: “Co-Registration Accuracy”stated without valueCI ≤ 5 mm
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

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

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc.) — same firm and product code, not necessarily this device · initiated 2023-07-12

    During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than expected and may result in detector 1 positioning further from the patient than needed leading to a reduction in image resolution.

    recall event 92704 (openFDA)

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc.) — same firm and product code, not necessarily this device · initiated 2023-01-16

    This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.

    recall event 91518 (openFDA)

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc.) — same firm and product code, not necessarily this device · initiated 2023-01-16

    This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.

    recall event 91518 (openFDA)

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc.) — same firm and product code, not necessarily this device · initiated 2023-01-16

    This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.

    recall event 91518 (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/K231833