Vivid Pioneer

K251169

GE Medical Systems Ultrasound and Primary Care Diagnostics · cleared 2025-07-10 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.6)
“The proposed Vivid Pioneer is a general purpose, Track 3, diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. It provides digital acquisition, processing, display and analysis capabilities. It consists of a mobile console with a height-adjustable control panel, color LCD touch panel, and a display monitor. Vivid Pioneer includes a variety of electronic array transducers operating in linear, curved, sector/phased array, matrix array or dual array format, including dedicated CW transducers and real time 3D transducer. The proposed Vivid Pioneer can be used with the stated compatible OEM ICE transducers. The system includes capability to output data to other devices like printing devices. The user-interface includes an operator control panel, a 23.8" High-Definition Ultrasound LCD type of display monitor (mounted on an arm for rotation and / or adjustment of height), a layout of pre-defined user controls (hard-keys) and a 15.6-inch multi-touch LCD panel with mode- and operation dependent soft-keys. The operator panel also includes two loudspeakers for audio, shelves for convenient placement of papers or accessories, and 6 holders with cable management for the connected transducers. The lower console is mounted on 4 rotational wheels with brakes, for ergonomic transport and safe parking. The lower console also includes all electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, hard copy printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection. AI Cardiac Auto Doppler: AI based algorithm for auto-tracing of additional doppler spectrums added to the predicate Cardiac Auto Doppler available in the predicate Vivid E95 (K220882), introducing additional heart valve related measurements compared to the predicate Spectrum Recognition algorithm available in Vivid E95 (K220882). AI FlexiViews LAA: AI based workflow tool to help localize the LAA (Left Atrial Appendage) anatomical structure in real-time 2D or Biplane images with a single button press. Similar functionality to 4D Zoom Prepare, 4D, and Flexi-Slice features in Vivid E95 (K220882).”
AlgorithmAI based algorithm for auto-tracing of additional doppler spectrums and AI based workflow tool to help localize the LAA (Left Atrial Appendage) anatomical structure. The AI Auto Doppler feature utilizes 2 AI algorithms, Tissue Doppler and Doppler Trace.
source quote (p.8)
“AI Cardiac Auto Doppler: AI based algorithm for auto-tracing of additional doppler spectrums added to the predicate Cardiac Auto Doppler available in the predicate Vivid E95 (K220882), introducing additional heart valve related measurements compared to the predicate Spectrum Recognition algorithm available in Vivid E95 (K220882). AI FlexiViews LAA: AI based workflow tool to help localize the LAA (Left Atrial Appendage) anatomical structure in real-time 2D or Biplane images with a single button press. Similar functionality to 4D Zoom Prepare, 4D, and Flexi-Slice features in Vivid E95 (K220882). The AI Auto Doppler feature utilizes 2 AI algorithms, Tissue Doppler and Doppler Trace, which are referenced below.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.10)
“Archive: With the proposed Vivid Pioneer both the patient archive and the operating system are encrypted. Instant Store: Background processing for storing images without impacting ongoing real time scanning. Secure Wipe: Admin user is allowed to securely delete all data on the device, including all Person Identifiable Information / Personal Health Information. NTP Clock Sync: Admin user is allowed to configure the system to do automatic clock synchronization to a selected Network Time Protocol server. eDelivery: The proposed Vivid Pioneer will enable download and install of partial system updates (patches) of the Windows OS made available from the GE HealthCare server.”

Validation studies (2)

Retrospective clinical

n=1,369 patients

endpoints: feasibility score of more than 95%; mean absolute difference in percentage for each measured parameter; mean percent absolute error across all cardiac cycles; agreement between manual and AI-derived peak velocities

Retrospective clinical

n=84 patients

endpoints: verification success rate; sensitivity; specificity; success rate of LAA region localization and landmark extraction

Reported performance (3 observations)

sensitivity84.91
source quote (p.14)
“The model achieved a verification success rate of 85%, with a sensitivity of 84.91% and a specificity of 91.82%”
specificity91.82
source quote (p.14)
“The model achieved a verification success rate of 85%, with a sensitivity of 84.91% and a specificity of 91.82%”
accuracyas written: “accuracy for individuals with BMI above 25”85
source quote (p.14)
“Analysis of the subset with available BMI data showed strong model performance, with over 85% accuracy for individuals with a BMI above 25.”

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

85
recalls in product code, 24mo
554
MAUDE reports in code, 12mo
+85%
vs code's own 3-yr baseline
4
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code IYN (GE Medical Systems, LLC, initiated 2025-09-18): "The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinica" Recalling firm matches this device's applicant.

    first seen 2026-07-08 · recall res_event_number:97726

  • recall_reason_pattern

    Software/algorithm-related recall in product code IYN (Philips Ultrasound, LLC, initiated 2025-10-31): "Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97843

  • recall_reason_pattern

    Software/algorithm-related recall in product code IYN (GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No., initiated 2025-05-16): "GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previou" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:96992

  • recall_reason_pattern

    Software/algorithm-related recall in product code IYN (Siemens Medical Solutions USA, Inc., initiated 2024-08-15): "If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems wi" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95254

Recalls attributed to this device

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · initiated 2025-09-18

    The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.

    recall event 97726 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · initiated 2025-09-18

    The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.

    recall event 97726 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · initiated 2025-09-18

    The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.

    recall event 97726 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · initiated 2025-03-06

    The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.

    recall event 96538 (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/K251169