FDA-cleared profile
BK Medical Aps
Authorized purpose: Ultrasound System 2300 provides diagnostic ultrasound, fluid-flow analysis, and puncture or biopsy guidance across fetal and obstetric, abdominal, pediatric, intraoperative, small-organ, cardiac, transesophageal, vascular, musculoskeletal, thoracic, and transrectal or transvaginal applications; it is not for ophthalmic imaging or through-the-eye use.
Product overview
Authorized purpose: Ultrasound System 2300 provides diagnostic ultrasound, fluid-flow analysis, and puncture or biopsy guidance across fetal and obstetric, abdominal, pediatric, intraoperative, small-organ, cardiac, transesophageal, vascular, musculoskeletal, thoracic, and transrectal or transvaginal applications; it is not for ophthalmic imaging or through-the-eye use.
Overview status: Source-reviewed overview
Clinical role: Ultrasound System 2300 provides diagnostic ultrasound, fluid-flow analysis, and puncture or biopsy guidance across fetal and obstetric, abdominal, pediatric, intraoperative, small-organ, cardiac, transesophageal, vascular, musculoskeletal, thoracic, and transrectal or transvaginal applications; it is not for ophthalmic imaging or through-the-eye use.
Evidence from the reviewed source record: K223830 reports system, probe, software, image-quality, Doppler, and workflow verification and validation for the labeled applications. Adult cardiac use is not direct imaging through the heart, ophthalmic use is excluded, and the public package does not establish a clinical sensitivity or specificity value.
Clinical details
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.
The exact indication uses this general qualification and does not identify physicians, sonographers, or other subgroups.
The exact device description establishes digital acquisition and supported transducers; it does not establish imported ultrasound data.
The exact packet supports acquisition, processing, display, measurements/calculations, and needle-guide visualization but not the broader reports/overlays wording.
These are the exact contraindication statements in the packet.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
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.
Map the installed model, build, options, population, anatomy, inputs, outputs, and enabled AI functions to K223830 before acceptance.
exact submission · checked 2026-09-03Later product-family features are not evidence that this cleared release includes them.
Validate supported probes and host devices, patient matching, DICOM or local export, PACS measurements, worklist, report transfer, and offline or downtime behavior.
exact submission · checked 2026-09-03Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally. The capability is derived from the exact FDA workflow and still requires local acceptance testing.
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. Use only labeled probes, modes, anatomies, patient populations, and guidance workflows. The system is not for ophthalmic imaging or through-the-eye use; the operator must confirm image quality and procedural anatomy.
exact submission · checked 2026-09-03Define 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.
product family · checked 2026-09-03No exact-product price was found in the reviewed public material; vendor productivity claims are scenario inputs, not guaranteed local savings.
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: Use only labeled probes, modes, anatomies, patient populations, and guidance workflows. The system is not for ophthalmic imaging or through-the-eye use; the operator must confirm image quality and procedural anatomy.
exact submission · checked 2026-09-03Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. The capability is derived from the exact FDA workflow and still requires local acceptance testing.
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.
Sensitivity is not the primary endpoint for this system, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.
Specificity is not the primary endpoint for this system, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
K223830
Manufacturer evidence submitted for FDA clearance or approval; local clinical, technical, and workflow acceptance remains necessary.
Costs and setup
These are common procurement questions; unknown values remain visible until a source supports them.
No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.
No separate named-product payment identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesBuild a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Each published event was manually matched to the exact FDA submission and affected product or version; a recall does not establish an AI-algorithm defect or current site exposure unless the event states that scope.
Open, Classified
2025-11-06Exact native submission match in the checked openFDA snapshot. Published as a product, system, labeling, or postmarket issue; do not infer an AI-algorithm defect unless the FDA record says so. Confirm affected model, version, units, corrective action, and completion status locally.
Open, Classified
2025-11-06Exact native submission match in the checked openFDA snapshot. Published as a product, system, labeling, or postmarket issue; do not infer an AI-algorithm defect unless the FDA record says so. Confirm affected model, version, units, corrective action, and completion status locally.
Open, Classified
2025-11-06Exact native submission match in the checked openFDA snapshot. Published as a product, system, labeling, or postmarket issue; do not infer an AI-algorithm defect unless the FDA record says so. Confirm affected model, version, units, corrective action, and completion status locally.
Open, Classified
2025-11-06Exact native submission match in the checked openFDA snapshot. Published as a product, system, labeling, or postmarket issue; do not infer an AI-algorithm defect unless the FDA record says so. Confirm affected model, version, units, corrective action, and completion status locally.
Open, Classified
2024-10-18Exact native submission match in the checked openFDA snapshot. Published as a product, system, labeling, or postmarket issue; do not infer an AI-algorithm defect unless the FDA record says so. Confirm affected model, version, units, corrective action, and completion status locally.
Open, Classified
2024-01-25Exact native submission match in the checked openFDA snapshot. Published as a product, system, labeling, or postmarket issue; do not infer an AI-algorithm defect unless the FDA record says so. Confirm affected model, version, units, corrective action, and completion status locally.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
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. 6 FDA recall candidates were manually reviewed: 6 published and 0 rejected as a neighboring or otherwise inapplicable version. Native FDA recall identifiers produced 6 postmarket candidate records; 6 have been reviewed (6 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, fda decision summary packet, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
Open the ledger for source dates, scope, and research-record updates.
Scope: purpose, modality, anatomy, evidenceSummary, intendedUsers, input, output, limitations, clinicalUse
Scope: regulatoryIdentity, modalityContext
Scope: postmarketSafety, affectedProduct, recallStatus, correctiveAction
Scope: postmarketSafety, affectedProduct, recallStatus, correctiveAction
Scope: postmarketSafety, affectedProduct, recallStatus, correctiveAction
Scope: postmarketSafety, affectedProduct, recallStatus, correctiveAction
Scope: postmarketSafety, affectedProduct, recallStatus, correctiveAction
Scope: postmarketSafety, affectedProduct, recallStatus, correctiveAction
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: coverage, codingContext
Scope: recallDiscovery, nativeSubmissionMatching
Regulatory record
510(k)
Research record
human reviewed
Editorial review
Source-reviewed editorial overlay
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