Radiology AI Directory

FDA-cleared profile

HM70 EVO Diagnostic Ultrasound System

Samsung Medison CO., LTD.

Authorized purpose: The HM70 EVO diagnostic ultrasound system and probes obtain ultrasound images and analyze body fluids for the listed fetal, obstetric, abdominal, gynecologic, pediatric, small-organ, cephalic, transrectal, transvaginal, musculoskeletal, urologic, cardiac, vascular, lung, and dermatologic applications under appropriately trained healthcare-professional supervision.

Cardiac imagingUltrasound workflow
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Product overview

Start with the essentials

Authorized purpose: The HM70 EVO diagnostic ultrasound system and probes obtain ultrasound images and analyze body fluids for the listed fetal, obstetric, abdominal, gynecologic, pediatric, small-organ, cephalic, transrectal, transvaginal, musculoskeletal, urologic, cardiac, vascular, lung, and dermatologic applications under appropriately trained healthcare-professional supervision.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: The HM70 EVO diagnostic ultrasound system and probes obtain ultrasound images and analyze body fluids for the listed fetal, obstetric, abdominal, gynecologic, pediatric, small-organ, cephalic, transrectal, transvaginal, musculoskeletal, urologic, cardiac, vascular, lung, and dermatologic applications under appropriately trained healthcare-professional supervision.

Evidence takeaway

Evidence from the reviewed source record: The exact FDA decision material for K233112 supports the submission-specific intended use and regulatory verification summarized here; it does not establish a general product-wide sensitivity or specificity value.

Clinical details

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
The HM70 EVO diagnostic ultrasound system and probes obtain ultrasound images and analyze body fluids for the listed fetal, obstetric, abdominal, gynecologic, pediatric, small-organ, cephalic, transrectal, transvaginal, musculoskeletal, urologic, cardiac, vascular, lung, and dermatologic applications under appropriately trained healthcare-professional supervision.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Appropriately trained healthcare professionals qualified for direct use of diagnostic ultrasound equipment.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Hospital, clinic, private practice, emergency, operating-room, or other labeled clinical environment.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
Diagnostic ultrasound imaging, fluid analysis, measurement, display, and analysis using the exact labeled probes and modes.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
Ultrasound acquisitions and fluid information from supported probes, applications, patient populations, and operating modes.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
Ultrasound images, measurements, Doppler or other mode-specific information, and fluid-analysis results for professional interpretation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
Use only the exact labeled probes, applications, modes, patient populations, and care settings; output requires qualified-professional review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K233112
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Anatomy
Fetal/obstetric, abdominal, gynecologic, pediatric, small-organ, cephalic, transrectal, transvaginal, musculoskeletal, urologic, cardiac, vascular, lung, and dermatologic anatomy
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2023-12-21
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
Standards-based DICOM/PACS integration was identified in the FDA submission materials; compatibility with a specific PACS, RIS, EHR, or orchestrator requires confirmation.
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.

Deployment and data flow
On-premise
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.

Security and privacy
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

Public sources reviewed here do not establish the complete exact-release security posture, including identity, audit, encryption, retention, remote access, vulnerability management, backup, or incident response.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-08-13

Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-08-13

Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.

Workflow role

Diagnostic ultrasound imaging, fluid analysis, measurement, display, and analysis using the exact labeled probes and modes.

exact submission · checked 2026-09-04

Submission-anchored workflow summary, not a local acceptance or deployment result.

Source

Input

Ultrasound acquisitions and fluid information from supported probes, applications, patient populations, and operating modes.

exact submission · checked 2026-09-04

Exact supported inputs and protocol limits must be confirmed from the complete labeling.

Source

Output

Ultrasound images, measurements, Doppler or other mode-specific information, and fluid-analysis results for professional interpretation.

exact submission · checked 2026-09-04

Output review, editing, approval, export, and downstream use remain release- and site-specific.

Source

Deployment evidence

Exact deployment topology and operational boundaries remain unestablished.

exact submission · checked 2026-09-04

Confirm hosting, PHI flow, retention, access, updates, downtime, and support obligations before procurement or clinical use.

Source

Integration evidence

Exact local interfaces, identity matching, routing, display, reporting, and fallback behavior remain unestablished.

exact submission · checked 2026-09-04

Validate the local workflow against the exact release and enabled options.

Source

Vendor family context

Current vendor material is product-family context for K233112 only; exact release, enabled options, deployment, security, interoperability, pricing, and local workflow require confirmation.

product family · checked 2026-09-04

Vendor material is not exact-release evidence unless that linkage is separately proven.

Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.

Evidence summary
The exact FDA decision material for K233112 supports the submission-specific intended use and regulatory verification summarized here; it does not establish a general product-wide sensitivity or specificity value.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Reported sensitivity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No exact-submission and version-linked sensitivity endpoint is promoted; candidate or product-family values were not substituted.

Reported specificity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No exact-submission and version-linked specificity endpoint is promoted; candidate or product-family values were not substituted.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

FDA submission-specific verification and validation evidence for K233112

  • DesignFDA 510(k) regulatory decision material and submission-specific verification or validation evidence for K233112; this is regulatory evidence, not an independent clinical effectiveness study.
  • PopulationThe labeled population, anatomy, images, and test materials described in the exact FDA decision material for K233112; a broader clinical population is not established here.
  • Scopeexact submission
  • Tested versionHM70 EVO Diagnostic Ultrasound System (K233112)
  • IndependenceSponsor or vendor study

K233112

The exact FDA material is submission-specific and should not be generalized to other versions, enabled options, sites, protocols, or clinical outcomes.

Source

Costs and setup

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No public exact-release price, license fee, subscription, contract, or implementation cost was established in this review.

Reimbursement and coding
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

CMS coverage-index context was checked, but no product-specific coverage or reimbursement determination is inferred.

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Exact FDA record reviewedStatus
2026-09-20Last searched
31Fields reviewed
13Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

Source classes: fda ai list, fda decision summary, vendor product page, implementation documentation, reimbursement policy, peer reviewed literature, clinical trial registry, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall

Sources & history

How this profile was documented

Open the ledger for source dates, scope, and research-record updates.

View source ledger and history

Source ledger

  1. FDA 510(k) decision material K233112: HM70 EVO Diagnostic Ultrasound System

    U.S. Food and Drug Administration - Published 2023-12-21 - Accessed 2026-09-04

    Scope: identity, productIdentity, purpose, clinicalUse, modality, anatomy, intendedUsers, careSetting, workflowRole, input, output, limitations, evidenceSummary

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  4. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  5. Medicare Coverage Database

    Centers for Medicare & Medicaid Services - Accessed 2026-09-01

    Scope: coverage, codingContext

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. Samsung ultrasound family context

    Samsung Healthcare - Accessed 2026-09-04

    Scope: productFamilyContext

Research history

  1. K233112 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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