Voluson Signature 20, Voluson Signature 18
K233692GE Medical Systems Ultrasound and Primary care Diagnostics, · cleared 2024-03-07 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“Voluson Signature 18 / Voluson Signature 20 system are a general-purpose diagnostic ultrasound system intended for use by a qualified and trained healthcare professional that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices for ultrasound imaging, measurement, display and analysis of the human body and fluid.”
source quote (p.9)
“The following software features have been migrated from Voluson SWIFT, Voluson SWIFT+(K230346): Fetal Heart Support, SonoAVCfollicle-auto caliper placement, Autolive, AVURI, SpineTrace, eDelivery(SW download), BPP Clock, Reminders, Voluson Remote Update, Shadow Reduction and Flow Profiles. The following software features have been migrated from Voluson Expert 22/20/18 (K231965): Shearwave Elastography, Perspective Rendering, Advanced STIC, Slowflow HD, SonoLyst(IR/X/Live), Fibroid Mapping (part of Option SonoGYN), SonoPelvicFloor 2.0, Ophthalmic Artery, Voluson Image Portal, Augment. The following software feature has been migrated from LOGIQ E10s/Fortis (K231989): Vscan Air CL Probe Support. The proposed Voluson Signature 20/18 adds the following new feature: Voice command.”
source quote (p.1)
“Specifically, FDA is updating this SE Letter because FDA inadvertently indicated that the SE determination also included review and clearance of a predetermined change control plan (PCCP). However, your 510(k) submission did not include a PCCP, so FDA is providing this administrative correction.”
Validation studies (1)
Bench
sample size not stated
endpoints: acoustic output; biocompatibility; cleaning and disinfection effectiveness; thermal safety; electrical safety; electromagnetic safety; mechanical safety
standards: AAMI/ANSI ES60601-1, Medical Electrical Equipment – Part 1: General Requirements for Safety, 2005/A2:2021, IEC 60601-1-2 Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbance - Requirements and Tests, Edition 4.1, 2020, IEC 60601-2-37, Medical Electrical Equipment – Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, Edition 2.1, 2015, ISO 10993-1, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within A Risk Management Process, Fifth edition, 2018, ISO 14971, Application of risk management to medical devices, 2019, NEMA PS 3.1 - 3.20, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology), 2021, IEC 62359, Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, Edition 2.1, 2017
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
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).