FDA-cleared profile

MI View&GO

Siemens Medical Solutions USA, Inc.

MI View&GO is a medical diagnostic application for viewing, manipulating, quantifying, analyzing, and comparing PET, nuclear-medicine, CT, and MR images across one or more time points, including labeled oncology, cardiology, neurology, organ-function, and radiotherapy-planning workflows.

Radiotherapy planning Cardiac imaging Oncology quantification Quantification and segmentation

Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.

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: MI View&GO is a medical diagnostic application for viewing, manipulating, quantifying, analyzing, and comparing PET, nuclear-medicine, CT, and MR images across one or more time points, including labeled oncology, cardiology, neurology, organ-function, and radiotherapy-planning workflows.

Intended users: Radiologists, physicians, technologists, surgeons, and other trained clinical image users.

Care setting and population: Hospital, outpatient, operating-room, or clinical image-review environments.

Workflow role: Medical-image display, manipulation, quantification, comparison, three-dimensional visualization, and planning support.

Required input: Supported DICOM PET, nuclear-medicine, CT, MR, or other medical images and user annotations.

Output and human action: Displayed images, reformats, measurements, quantification, comparisons, and reports for professional review.

Limitations: Supported modalities, applications, display paths, quantitative methods, and licensed features vary by exact release; primary interpretation and planning decisions require trained professionals.

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: K254016

Modality: Radiological images; modality varies or is not specified in FDA list

Anatomy: Whole body, organs, tumors, heart, brain, and oncology regions

Clearance type: 510(k)

Decision date: 2026-02-10

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: The exact FDA material describes client and server components and multimodality image import and export; validate DICOM, identity, worklist, licensing, routing, and report workflow locally.

Deployment and data flow: Not established in reviewed sources

Security and privacy: Vendor documentation pending

Training and support: Only radiologists, physicians, technologists, surgeons, and other trained clinical image users 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: Supported modalities, applications, display paths, quantitative methods, and licensed features vary by exact release; primary interpretation and planning decisions require trained professionals.

Release and scope verification

Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K254016 before acceptance.

exact submission · checked 2026-09-04

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

Source

Interoperability acceptance

The exact FDA material describes client and server components and multimodality image import and export; validate DICOM, identity, worklist, licensing, routing, and report workflow locally.

product family · checked 2026-09-04

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally. Current vendor material is product-family context; confirm exact release, enabled options, deployment, and local compatibility.

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. Supported modalities, applications, display paths, quantitative methods, and licensed features vary by exact release; primary interpretation and planning decisions require trained professionals.

exact submission · checked 2026-09-04

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 2026-09-04

No exact-product price was found in the reviewed public material; productivity or value claims require local evidence.

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: Supported modalities, applications, display paths, quantitative methods, and licensed features vary by exact release; primary interpretation and planning decisions require trained professionals.

product family · checked 2026-09-04

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. Current vendor material is product-family context; confirm exact release, enabled options, deployment, and local compatibility.

Source Source

Evidence

Performance evidence

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

Evidence summary: The exact FDA decision material describes the VA40 software, client and server architecture, PET and nuclear-medicine quantification, CT and MR support, and professional review. Feature licenses and deployment topology require exact-site confirmation.

Reported sensitivity: Not applicable

Reported specificity: Not applicable

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

K254016 FDA evidence package for MI View&GO

FDA software substantial-equivalence decision with image-display, quantification, segmentation, comparison, DICOM, and usability verification · Multimodality diagnostic and treatment-planning image review by trained healthcare professionals

exact submission · Tested version: MI View&GO VA40 described in K254016 · Sponsor or vendor study

K254016

Manufacturer evidence submitted for the exact FDA decision. It is not independent clinical validation, and local technical, clinical, privacy, security, and workflow acceptance remains necessary.

Source

Economics and lifecycle

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

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, or surgical service line and verify payer, site-of-service, and coding assumptions independently.

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

Build a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.

Source

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: The 2026-09-02 openFDA device-recall snapshot contained no record matched to K254016 by exact native submission identifier. This does not exclude product-family, later, or adverse-event information.

Buyer worksheet

Open questions to take to the vendor

Verify deployment and data flow: The public exact-submission 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 configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Open evaluation checklist

Research record

What has been checked

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

Human reviewedStatus

2026-09-04Last searched

26Fields reviewed

10Source classes checked

0Unreviewed PubMed leads

0Unreviewed trial leads

0Unreviewed FDA recall leads

This submission was added after the prior exact-submission extraction and remains queued for source review. Exact-name and exact-submission searches in the checked 2026-09-01 indexes returned no PubMed records and no ClinicalTrials.gov records for K254016; review status is candidate_review_pending. Any candidate literature or registry record remains quarantined as product-family evidence unless exact submission and version linkage is established. Current vendor material is product-family context. Pricing, complete security architecture, contracted deployment, exact reimbursement, and local interoperability remain unverified. 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 material, vendor product page, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall

Sources

Source ledger

Sources accessed through 2026-09-04.

FDA 510(k) decision material K254016: MI View&GO 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
Siemens MI View&GO family Siemens Healthineers · 2026-09-04

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