Vivid E80, Vivid E90, Vivid E95

K220882

GE Medical Systems Ultrasound and · cleared 2022-07-22 · product code IYN · Radiology

FDA 510(k) summary for Vivid E80, Vivid E90, Vivid E95 (K220882)

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
1
Cited predicates
6
Performance observations
3
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.6)
“Vivid™ E80 / Vivid E90 / Vivid E95 is a Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. It is a full featured diagnostic ultrasound system that provides digital acquisition, processing, analysis and display capabilities. Added Easy Auto EF -based on Auto EF 3.0 (includes AI Auto ROI algorithm)”
AlgorithmAI algorithm (average dice score) for Easy Auto EF and Easy AFI LV.
source quote (p.8)
“The accuracy of the AI algorithm (average dice score) as tested on datasets from different countries, is 92% or higher; as tested on datasets from different scanning views, is 91% or higher; as tested on dataset from different left ventricle volumes, is 92% or higher.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=45 patients

endpoints: accuracy of the AI algorithm (average dice score)

Reported performance (3 observations)

diceas written: “average dice score (overall)”0.92CI 92% or higher
source quote (p.8)
“The accuracy of the AI algorithm (average dice score) as tested on datasets from different countries, is 92% or higher”
diceas written: “average dice score (different scanning views)”0.91CI 91% or higher
source quote (p.8)
“as tested on datasets from different scanning views, is 91% or higher”
diceas written: “average dice score (different left ventricle volumes)”0.92CI 92% or higher
source quote (p.8)
“as tested on dataset from different left ventricle volumes, is 92% 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
10
drift signals on this device
  • predicate_cohort_contagion

    K220882 shares predicate K181685 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:K181685 sibling:K251342

  • predicate_cohort_contagion

    K220882 shares predicate K202132 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:K202132 sibling:K220940

  • predicate_cohort_contagion

    K220882 shares predicate K181685 with K200852 (EchoPAC Software Only, EchoPAC Plug-In), whose product code LLZ recorded 48 recall event(s) in the trailing 24 months.

    first seen 2026-07-15 · predicate:K181685 sibling:K200852

  • 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) K243628 (decision 2025-02-11) from GE Medical Systems Ultrasound and Primary Care Diagnostics for a matching device line ("Vivid T9/Vivid T8") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K243628

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K243620 (decision 2025-02-11) from GE Medical Systems Ultrasound and Primary Care Diagnostics for a matching device line ("Vivid iq") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K243620

  • …and 4 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

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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/K220882