FDA-cleared profile
Shanghai United Imaging Healthcare Co., Ltd
Authorized purpose: uOmnispace is software for viewing, manipulating, communicating, storing, processing, and filming multimodality DICOM images, usable stand-alone or with cleared software options and multi-vendor applications meeting interface requirements; it is not intended to display digital mammography images for diagnosis in the United States.
Product overview
Authorized purpose: uOmnispace is software for viewing, manipulating, communicating, storing, processing, and filming multimodality DICOM images, usable stand-alone or with cleared software options and multi-vendor applications meeting interface requirements; it is not intended to display digital mammography images for diagnosis in the United States.
Overview status: Source-reviewed overview
Clinical role: uOmnispace is software for viewing, manipulating, communicating, storing, processing, and filming multimodality DICOM images, usable stand-alone or with cleared software options and multi-vendor applications meeting interface requirements; it is not intended to display digital mammography images for diagnosis in the United States.
Evidence from the reviewed source record: The exact FDA decision material for K230039 supports the submission-specific intended use and regulatory verification summarized here; it does not establish a general product-wide sensitivity or specificity value.
Clinical details
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
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.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
Public sources reviewed here do not establish the complete exact-release security posture, including identity, audit, encryption, retention, remote access, vulnerability management, backup, or incident response.
Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Medical-image viewing, processing, segmentation, measurement, registration, communication, or planning support within the exact labeled scope.
exact submission · checked 2026-09-04Submission-anchored workflow summary, not a local acceptance or deployment result.
DICOM or other medical-image data from the exact labeled modalities, scanners, and user workflow.
exact submission · checked 2026-09-04Exact supported inputs and protocol limits must be confirmed from the complete labeling.
Images, measurements, segmentations, models, reports, or planning information for professional review.
exact submission · checked 2026-09-04Output review, editing, approval, export, and downstream use remain release- and site-specific.
The exact FDA indication describes stand-alone use or use with cleared software options and compatible multi-vendor applications; hosting, server topology, retention, and local operational requirements are not established.
exact submission · checked 2026-09-04Confirm hosting, PHI flow, retention, access, updates, downtime, and support obligations before procurement or clinical use.
The exact FDA indication describes plug-in multi-vendor applications that meet interface requirements; local PACS, identity, routing, storage, and application compatibility require confirmation.
exact submission · checked 2026-09-04Validate the local workflow against the exact release and enabled options.
Current vendor material is product-family context for K230039 only; exact release, enabled options, deployment, security, interoperability, pricing, and local workflow require confirmation.
product family · checked 2026-09-04Vendor material is not exact-release evidence unless that linkage is separately proven.
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.
No exact-submission and version-linked sensitivity endpoint is promoted; candidate or product-family values were not substituted.
No exact-submission and version-linked specificity endpoint is promoted; candidate or product-family values were not substituted.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
K230039
The exact FDA material is submission-specific and should not be generalized to other versions, enabled options, sites, protocols, or clinical outcomes.
Costs and setup
These are common procurement questions; unknown values remain visible until a source supports them.
No public exact-release price, license fee, subscription, contract, or implementation cost was established in this review.
CMS coverage-index context was checked, but no product-specific coverage or reimbursement determination is inferred.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
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. 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, vendor product page, implementation documentation, reimbursement policy, peer reviewed literature, clinical trial registry, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
Open the ledger for source dates, scope, and research-record updates.
Scope: identity, productIdentity, purpose, clinicalUse, modality, anatomy, intendedUsers, careSetting, workflowRole, input, output, limitations, evidenceSummary
Scope: regulatoryIdentity, modalityContext
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: coverage, codingContext
Scope: recallDiscovery, nativeSubmissionMatching
Scope: productFamilyContext
Regulatory record
510(k)
Research record
fda record reviewed
Editorial review
Source-reviewed editorial overlay
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