EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

Evidence summary

The exact FDA decision material describes the labeled intended use and submission-level verification for this release. It does not establish a product-wide clinical sensitivity or specificity claim or independent clinical outcome evidence.

FDA source Exact FDA submission Checked 2026-09-04

• Source

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

Postmarket safety review

The 2026-09-02 openFDA device-recall snapshot contained no record matched to K251455 by native exact 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.

• Source

• Verify deployment and data flow: Deployment details for the exact cleared configuration are not established in the public FDA decision material.
• Verify security and privacy controls: Security controls, hosting boundaries, audit behavior, identity management, and incident commitments for the exact configuration are not established in the public FDA decision material.
• Verify pricing and total cost: No public list price for the exact cleared configuration was found in the evidence set. Obtain a written quote covering license or hardware basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, downtime, and exit costs.
• Verify local validation and lifecycle monitoring: Post-deployment monitoring, drift thresholds, alerting, and revalidation commitments for the exact configuration require vendor and site confirmation.

Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA decision material was reviewed for identity and labeled use. Optional literature, trial, and recall candidates were not promoted without exact product or version applicability; commercial, security, and performance claims remain unknown where not established. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, fda decision summary, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall

• FDA 510(k) decision material K251455: EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System U.S. Food and Drug Administration · 2026-09-04
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
• ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
• Medicare Coverage Database Centers for Medicare & Medicaid Services · 2026-09-01
• openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02