Authorized purpose: The Samsung V5, H5, XV5, XH5, V4, H4, XV4, and XH4 diagnostic ultrasound systems are intended for diagnostic ultrasound imaging and fluid analysis of the human body by appropriately trained healthcare professionals across the labeled adult, pediatric, fetal, obstetric, abdominal, gynecologic, cardiac, vascular, cephalic, small-organ, musculoskeletal, urologic, and procedural applications.
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 Samsung V5, H5, XV5, XH5, V4, H4, XV4, and XH4 diagnostic ultrasound systems are intended for diagnostic ultrasound imaging and fluid analysis of the human body by appropriately trained healthcare professionals across the labeled adult, pediatric, fetal, obstetric, abdominal, gynecologic, cardiac, vascular, cephalic, small-organ, musculoskeletal, urologic, and procedural applications.
Overview status: Source-reviewed overview
What does this software do?Authorized purpose: The Samsung V5, H5, XV5, XH5, V4, H4, XV4, and XH4 diagnostic ultrasound systems are intended for diagnostic ultrasound imaging and fluid analysis of the human body by appropriately trained healthcare professionals across the labeled adult, pediatric, fetal, obstetric, abdominal, gynecologic, cardiac, vascular, cephalic, small-organ, musculoskeletal, urologic, and procedural applications.
Which images or clinical context are in scope?Modality: Ultrasound Anatomy or clinical context: Fetal/obstetric, abdominal, pelvic, cardiac, vascular, cephalic, small-organ, musculoskeletal, and urologic anatomy Input: Ultrasound data acquired with the exact labeled system, transducers, patient, application, and operating mode.
Who uses it?Intended users: Appropriately trained healthcare professionals qualified for direct use of diagnostic ultrasound devices.
What does the software produce?Output: Ultrasound images, signals, measurements, calculations, and displayed or recorded results for professional review.
What is its most important limitation?Key limitation: The FDA material describes multiple models, probes, applications, and operating modes. A buyer must map the installed model and enabled options to the exact submission and labeling; clinical judgment remains required.
Clinical takeaway
Clinical role: The Samsung V5, H5, XV5, XH5, V4, H4, XV4, and XH4 diagnostic ultrasound systems are intended for diagnostic ultrasound imaging and fluid analysis of the human body by appropriately trained healthcare professionals across the labeled adult, pediatric, fetal, obstetric, abdominal, gynecologic, cardiac, vascular, cephalic, small-organ, musculoskeletal, urologic, and procedural applications.
Evidence takeaway
Evidence from the reviewed source record: The exact FDA 510(k) decision material for K242511 identifies V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System and describes the indicated use summarized in this dossier. It is regulatory evidence for the exact submission, not independent clinical validation. No performance or outcome claim is promoted without exact product and version linkage.
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 Samsung V5, H5, XV5, XH5, V4, H4, XV4, and XH4 diagnostic ultrasound systems are intended for diagnostic ultrasound imaging and fluid analysis of the human body by appropriately trained healthcare professionals across the labeled adult, pediatric, fetal, obstetric, abdominal, gynecologic, cardiac, vascular, cephalic, small-organ, musculoskeletal, urologic, and procedural applications.
The FDA material describes multiple models, probes, applications, and operating modes. A buyer must map the installed model and enabled options to the exact submission and labeling; clinical judgment remains required.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
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.
The exact FDA decision material does not establish the complete deployment topology, hosting responsibility, availability, upgrade path, or service contract.
Security and privacy
Not established in reviewed sources
Reviewed sources checked
Exact FDA submission
Checked 2026-09-04
Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
Training and support
Only appropriately trained healthcare professionals qualified for direct use of diagnostic ultrasound devices should operate or interpret this product. Local onboarding should cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.
Monitor by exact hardware, software, model, algorithm, reconstruction, or configuration 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: The FDA material describes multiple models, probes, applications, and operating modes. A buyer must map the installed model and enabled options to the exact submission and labeling; clinical judgment remains required.
Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K242511 before acceptance. Later family features are not evidence for this exact submission.
The exact FDA material does not establish a complete interoperability contract. Establish and test supported input, output, identity, routing, archive, and downtime behavior locally.
The exact FDA material does not establish hosting, deployment topology, availability, upgrade path, or service responsibility. Obtain site-specific evidence before procurement.
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. The FDA material describes multiple models, probes, applications, and operating modes. A buyer must map the installed model and enabled options to the exact submission and labeling; clinical judgment remains required.
exact submission · checked 2026-09-04
Define stop-use, escalation, rollback, and revalidation triggers before production use.
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. No exact-product price was found.
Monitor by exact hardware, software, model, algorithm, reconstruction, or configuration 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: The FDA material describes multiple models, probes, applications, and operating modes. A buyer must map the installed model and enabled options to the exact submission and labeling; clinical judgment remains required.
exact submission · checked 2026-09-04
Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.
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 510(k) decision material for K242511 identifies V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System and describes the indicated use summarized in this dossier. It is regulatory evidence for the exact submission, not independent clinical validation. No performance or outcome claim is promoted without exact product and version linkage.
Sensitivity is not a product-wide endpoint for this system or software function. Compare only an exact endpoint, threshold, population, version, and source if later verified.
Reported specificity
Not applicable
Not applicable
Not applicable
Checked 2026-09-04
Specificity is not a product-wide endpoint for this system or software function. Compare only an exact endpoint, threshold, population, version, and source if later verified.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
DesignFDA 510(k) substantial-equivalence review of the exact submission, device description, indications, and verification or validation documentation.
Tested versionV5, H5, XV5, XH5, V4, H4, XV4, and XH4 Diagnostic Ultrasound Systems
IndependenceSponsor or vendor study
K242511
The FDA decision material is manufacturer-submitted regulatory evidence. It is not independent clinical validation, and local technical, clinical, privacy, security, and workflow acceptance remains necessary.
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 list price for the exact cleared or approved configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.
Reimbursement and coding
No separate named-product Medicare payment was identified in the reviewed CMS coverage material. Evaluate the product within the applicable imaging, procedural, surgical, or diagnostic service line and verify payer, site-of-service, and coding assumptions independently.
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Postmarket safety review
The 2026-09-02 openFDA device-recall snapshot contained no record matched to K242511 by exact native submission identifier. This does not exclude product-family, later, or adverse-event information.
Public source
Exact FDA submission
Checked 2026-09-04
Exact-identifier review does not prove absence of all product-family safety signals.
Verify deployment and data flow: The exact FDA decision material does not establish the complete deployment topology, hosting responsibility, availability, upgrade path, or service contract.
Verify security and privacy controls: Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
Verify pricing and total cost: No public list price for the exact cleared or approved configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-20Last searched
33Fields reviewed
12Source 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, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, 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 history6 sources - 3 history items
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