Voluson Expert 18; Voluson Expert 20; Voluson Expert 22

K242168

GE Medical Systems Ultrasound and Primary care Diagnostics · cleared 2024-12-20 · product code IYN · Radiology

FDA 510(k) summary for Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 (K242168)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
5
Cited predicates
4
Performance observations
9
Product code
IYN
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. The proposed Voluson Expert Series 18/20/22 adds additional AI software features SonoLyst 1st Trimester and Sono Pelvic floor 3.0: which includes MHD (valsava manoeuver detection) and Anal sphincter”
AlgorithmAI software features including SonoLyst 1st Trimester, Sono Pelvic floor 3.0 (MHD and Anal sphincter detection), SonoLyst 2nd Trimester, and SonoAVC follicle 2.0
source quote (p.7)
“The proposed Voluson Expert Series 18/20/22 adds additional AI software features SonoLyst 1st Trimester and Sono Pelvic floor 3.0: which includes MHD (valsava manoeuver detection) and Anal sphincter The proposed Voluson Expert Series 18/20/22 updated existing AI software features SonoLyst 2nd Trimester and SonoAVC follicle 2.0”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedNo

Validation studies (5)

Retrospective clinical

n=93 cases · 7 site(s)

endpoints: success rate

Retrospective clinical

n=106 cases · 5 site(s)

endpoints: success rate

Retrospective clinical

n=2,708 other · 5 site(s)

endpoints: Accuracy

Retrospective clinical

sample size not stated · 4 site(s)

endpoints: average agreement; average success rate

Retrospective clinical

sample size not stated

endpoints: average agreement; acceptability rate; average success rate

Reported performance (9 observations)

accuracyas written: “Accuracy (On test data acquired together with train cohort)”94.73
source quote (p.12)
“Accuracy: On test data acquired together with train cohort: 94.73%”
accuracyas written: “Accuracy (On test data, acquired consecutively post model development)”92.8
source quote (p.12)
“On test data, acquired consecutively post model development: 92.8%”
accuracyas written: “Overall Accuracy”93.6
source quote (p.12)
“Overall Accuracy: 93.6%”
diceas written: “Dice Coefficient (3-5 mm)”0.937619
source quote (p.13)
“3-5 0.937619”
diceas written: “Dice Coefficient (5-10 mm)”0.946289
source quote (p.13)
“5-10 0.946289”
diceas written: “Dice Coefficient (10-15 mm)”0.962315
source quote (p.13)
“10-15 0.962315”
diceas written: “Dice Coefficient (>15 mm)”0.93206
source quote (p.13)
“>15 0.93206”
accuracyas written: “average success rate of SonoLyst 2nd Trimester IR and X and overall traffic light accuracy”80CI or higher
source quote (p.15)
“The average success rate of SonoLyst 2nd Trimester IR and X and overall traffic light accuracy is 80% or higher”
accuracyas written: “average success rate of SonoLyst 1st Trimester IR, X and SonoBiometry CRL and overall traffic light accuracy”80CI or higher
source quote (p.17)
“The average success rate of SonoLyst 1st Trimester IR, X and SonoBiometry CRL and overall traffic light accuracy is 80% or higher”

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

25
recalls in product code, 24mo
594
MAUDE reports in code, 12mo
+95%
vs code's own 3-yr baseline
8
drift signals on this device
  • predicate_cohort_contagion

    K242168 shares predicate K211488 with K220940 (EchoPAC Software Only, EchoPAC Plug-in), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-08-26 · predicate:K211488 sibling:K220940

  • predicate_cohort_contagion

    K242168 shares predicate K231965 with K251342 (EchoPAC Software Only / EchoPAC Plug-in), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-08-26 · predicate:K231965 sibling:K251342

  • 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

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K252328 (decision 2025-11-24) from Ge Medical Systems Ultrasound and Primary Care Diagnostics for a matching device line ("Voluson Expert 18; Voluson Expert 20; Voluson Expert 22") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K252328

  • adverse_event_inflection

    MAUDE adverse-event reports for product code IYN: 604 in the 12 months ending 2026-06, vs a 298.7/12mo average over the prior 3 windows (+102%). Code-level count — reports are not attributed to this specific device.

    first seen 2026-07-15 · openFDA /device/event.json count=date_received product_code=IYN

  • 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

  • …and 2 more.

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)

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 2026-08-26.

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.

Related FDA clearances

More AI/ML devices under product code IYN

These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

Alturion Series Diagnostic Ultrasound System

K260667

Philips Ultrasound, LLC

cleared 2026-06-29

ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System

K260844

Siemens Medical Solutions USA, Inc.

cleared 2026-06-16

EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System

K253595

Philips Ultrasound, LLC

cleared 2026-03-27

Butterfly Gestational Age Tool

K252148

Butterfly Network, Inc.

cleared 2026-03-27

LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power

K260673

GE Medical Systems Ultrasound and Primary Care Diagnostics

cleared 2026-03-24

Sonio Detect (v3)

K252433

Sonio

cleared 2026-03-16

LOGIQ Totus

K253370

GE Medical Systems Ultrasound and Primary Care Diagnostics

cleared 2026-01-08

LOGIQ Fortis

K253366

GE Medical Systems Ultrasound and Primary Care Diagnostics

cleared 2026-01-07

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K242168