Vivid Pioneer
K251169GE Medical Systems Ultrasound and Primary Care Diagnostics · cleared 2025-07-10 · product code IYN · Radiology
Premarket evidence — what FDA accepted
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. 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).”
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.”
source quote (p.10)
“Archive: With the proposed Vivid Pioneer both the patient archive and the operating system are encrypted. 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
Retrospective clinical
n=84 patients
endpoints: success rate of LAA region localization and landmark extraction
Reported performance (2 observations)
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%”
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%”
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 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
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).