Clinical fit

What this tool is for

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

Exact purpose: The Samsung V-family diagnostic ultrasound systems support fetal and obstetric, abdominal, gynecologic, pediatric, small-organ, cephalic, cardiac, thoracic, vascular, musculoskeletal, urologic, transrectal, transvaginal, transesophageal, intraoperative, and dermatologic applications where labeled.

Intended users: Qualified physicians, sonographers, and other trained ultrasound professionals.

Care setting and population: Hospitals, clinics, offices, operating rooms, and point-of-care environments within the cleared applications.

Workflow role: Ultrasound acquisition, measurement, analysis, reporting, and release-specific AI assistance.

Required input: Live or imported ultrasound data from supported probes, systems, host devices, and applications.

Output and human action: Ultrasound images, measurements, calculations, overlays, and reports for clinician review.

Limitations: AI-assisted measurements, views, and guidance do not replace image-quality assessment or clinician interpretation; supported probes, host devices, populations, and features differ by release.

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: K250999

Modality: Ultrasound

Anatomy: Multi-region

Clearance type: 510(k)

Decision date: 2025-07-18

FDA status: FDA-cleared

Implementation

Questions for IT, informatics, and operations

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

Integration: Validate supported probes and host devices, patient matching, DICOM or local export, PACS measurements, worklist, report transfer, and offline or downtime behavior.

Deployment and data flow: Ultrasound hardware or software with supported probes, host devices, licensed options, and network configuration.

Security and privacy: Vendor documentation pending

Training and support: Only qualified physicians, sonographers, and other trained ultrasound professionals should operate or interpret the product. Local onboarding should cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.

Monitoring and change control: Monitor by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: AI-assisted measurements, views, and guidance do not replace image-quality assessment or clinician interpretation; supported probes, host devices, populations, and features differ by release.

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, outputs, and enabled AI functions to K250999 before acceptance.

exact submission · checked 2026-09-03

Later product-family features are not evidence that this cleared release includes them.

Source

Interoperability acceptance

Validate supported probes and host devices, patient matching, DICOM or local export, PACS measurements, worklist, report transfer, and offline or downtime behavior.

product family · checked 2026-09-03

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally. Vendor statements are current product-family context; confirm the exact cleared release and installed options.

Source Source

Clinical acceptance

Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. AI-assisted measurements, views, and guidance do not replace image-quality assessment or clinician interpretation; supported probes, host devices, populations, and features differ by release.

exact submission · checked 2026-09-03

Define stop-use, escalation, rollback, and revalidation triggers before production use.

Source

Economic evaluation

Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.

product family · checked 2026-09-03

No exact-product price was found in the reviewed public material; vendor productivity claims are scenario inputs, not guaranteed local savings.

Source

Lifecycle monitoring

Monitor by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: AI-assisted measurements, views, and guidance do not replace image-quality assessment or clinician interpretation; supported probes, host devices, populations, and features differ by release.

product family · checked 2026-09-03

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. Vendor statements are current product-family context; confirm the exact cleared release and installed options.

Source Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.

Evidence summary: K250999 reports AI fetal-biometry testing on 320 images from 52 patients in two countries, with Dice 0.869 and distance or circumference errors within the stated limits. ViewAssist testing included 680 images from 102 patients; fetal HeartAssist testing included 280 images from 70 patients. The reported performance is function-specific and does not characterize every V-family workflow.

Reported sensitivity: 0.9397 ViewAssist fetal-biometry sensitivity and 0.9429 fetal HeartAssist sensitivity; endpoint-specific

Reported specificity: 0.9962 for the reported ViewAssist and fetal HeartAssist evaluations; endpoint-specific

Fetal-biometry Dice

0.869 coefficient

Segmentation overlap in V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System.