Radiology AI Directory

FDA-cleared profile

SurgicalAR

MEDIVIS, Inc.

Authorized purpose: SurgicalAR displays CT and MR medical images and associated data as two-dimensional, multiplanar, three-dimensional, or volume-rendered views on a workstation, touchscreen, or head-mounted display to support surgical planning and intraoperative review; headset and mobile views are informational and non-diagnostic.

Radiological images; modality varies or is not specified in FDA list workflow
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: SurgicalAR displays CT and MR medical images and associated data as two-dimensional, multiplanar, three-dimensional, or volume-rendered views on a workstation, touchscreen, or head-mounted display to support surgical planning and intraoperative review; headset and mobile views are informational and non-diagnostic.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: SurgicalAR displays CT and MR medical images and associated data as two-dimensional, multiplanar, three-dimensional, or volume-rendered views on a workstation, touchscreen, or head-mounted display to support surgical planning and intraoperative review; headset and mobile views are informational and non-diagnostic.

Evidence takeaway

Evidence from the reviewed source record: K190764 reports DICOM handling, rendering, simulated-use, and human-factors validation. Headset and mobile views are informational and non-diagnostic, and lossy mammography or digitized-film images are not for primary interpretation; the FDA package does not establish a clinical-outcome or diagnostic-performance claim.

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
SurgicalAR displays CT and MR medical images and associated data as two-dimensional, multiplanar, three-dimensional, or volume-rendered views on a workstation, touchscreen, or head-mounted display to support surgical planning and intraoperative review; headset and mobile views are informational and non-diagnostic.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.

Intended users
Radiologists, surgeons, physicians, technologists, and other trained clinical image users.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Care setting and population
Hospital, outpatient, operating-room, or clinical image-review environments.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Workflow role
Medical-image display, manipulation, three-dimensional visualization, measurement, and planning support.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Required input
Patient CT/MR DICOM data.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The packet directly states the CT/MR DICOM input. Radiographic, fluoroscopic, and annotation-input wording in the current value is not established by the exact packet.

Output and human action
Display of medical images and other healthcare data, including image review, image manipulation, basic measurements, and 3D visualization with MPR reconstructions and 3D volume rendering.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact intended-use text supports display, review, manipulation, basic measurements, MPR, and 3D volume rendering; it does not state the current segmentation or registration outputs.

Limitations
Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. When accessing SurgicalAR from a wireless stereoscopic head-mounted display or mobile device, images viewed are for informational purposes only and not intended for diagnostic use.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

This replacement uses the packet's explicit mammography and HMD/mobile limitations and removes unsupported patient-identity, registration, and source-image review requirements.

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
K190764
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Radiological images; modality varies or is not specified in FDA list
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact device description states that the software loads patient CT/MR DICOM data; it does not support the current statement that the modality is unspecified. Controlled directory display reconciled from exact FDA wording: CT/MR DICOM data. -> Radiological images; modality varies or is not specified in FDA list.

Anatomy
Multi-region
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2019-05-13
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
DICOM import or network exchange with PACS, workstations, surgical systems, and archives; validate patient matching, display calibration, compression, export, and downtime.
  • Public source
  • Product family
  • Checked 2026-09-03

Current vendor materials are product-family evidence for K190764; confirm the exact cleared version, enabled options, deployment, and local compatibility.

Deployment and data flow
Release-specific workstation, server, or connected display and headset configuration.
  • Public source
  • Product family
  • Checked 2026-09-03

Current vendor materials are product-family evidence for K190764; confirm the exact cleared version, enabled options, deployment, and local compatibility.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-03

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 radiologists, surgeons, physicians, technologists, 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.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
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: Head-mounted and mobile views are informational and non-diagnostic. Lossy-compressed mammography and digitized-film images are not for primary interpretation; the display, registration, patient identity, and source-image review must be checked before use.
  • Public source
  • Product family
  • Checked 2026-09-03

Current vendor materials are product-family evidence for K190764; confirm the exact cleared version, enabled options, deployment, and local compatibility.

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, outputs, and enabled AI functions to K190764 before acceptance.

exact submission · checked 2026-09-03

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

Source

Interoperability acceptance

DICOM import or network exchange with PACS, workstations, surgical systems, and archives; validate patient matching, display calibration, compression, export, and downtime.

product family · checked 2026-09-03

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally. Vendor statements are current product-family context; confirm the exact cleared release and installed options.

SourceSource

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. Head-mounted and mobile views are informational and non-diagnostic. Lossy-compressed mammography and digitized-film images are not for primary interpretation; the display, registration, patient identity, and source-image review must be checked before use.

exact submission · checked 2026-09-03

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 2026-09-03

No exact-product price was found in the reviewed public material; vendor productivity claims are scenario inputs, not guaranteed local savings.

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: Head-mounted and mobile views are informational and non-diagnostic. Lossy-compressed mammography and digitized-film images are not for primary interpretation; the display, registration, patient identity, and source-image review must be checked before use.

product family · checked 2026-09-03

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. Vendor statements are current product-family context; confirm the exact cleared release and installed options.

SourceSource

Evidence

Performance 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.

Evidence summary
K190764 reports DICOM handling, rendering, simulated-use, and human-factors validation. Headset and mobile views are informational and non-diagnostic, and lossy mammography or digitized-film images are not for primary interpretation; the FDA package does not establish a clinical-outcome or diagnostic-performance claim.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Reported sensitivity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-03

Sensitivity is not the primary endpoint for this system, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.

Reported specificity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-03

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.

K190764 FDA performance package for SurgicalAR

  • DesignManufacturer DICOM, rendering, simulated-use, and human-factors validation
  • PopulationCT and MR surgical-planning or intraoperative image-review workflows with workstation, touchscreen, or headset display
  • Scopeexact submission
  • Tested versionSurgicalAR
  • IndependenceSponsor or vendor study

K190764

Manufacturer evidence submitted for FDA clearance or approval; local clinical, technical, and workflow acceptance remains necessary.

Source

4 unlinked candidate evidence records are retained for source review and excluded from this evidence display.

Costs and setup

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
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-03

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.

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.
  • Public source
  • Not applicable
  • Checked 2026-09-03

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 K190764 by exact submission identifier. This does not exclude product-family, later, or adverse-event information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03

Exact-identifier review does not prove absence of all product-family safety signals.

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

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

Exact FDA record reviewedStatus
2026-09-20Last searched
28Fields reviewed
14Source classes checked
5Screened PubMed leads
1Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains 5 PubMed and 1 ClinicalTrials.gov candidate records. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 5 PubMed and 1 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, vendor product page, 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

How this profile was documented

Open the ledger for source dates, scope, and research-record updates.

View source ledger and history

Source ledger

  1. FDA K190764: SurgicalAR

    U.S. Food and Drug Administration - Published 2019-05-13 - Accessed 2026-09-19

    Scope: purpose, anatomy, intendedUsers, modality, input, output, limitations, evidenceSummary, clinicalUse

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  4. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  5. Medicare Coverage Database

    Centers for Medicare & Medicaid Services - Accessed 2026-09-01

    Scope: coverage, codingContext

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. Medivis SurgicalAR

    Medivis - Accessed 2026-09-03

    Scope: productFamilyContext, workflowRole, implementationCapabilities

  8. Augmented Reality-Assisted Percutaneous Rhizotomy for Trigeminal Neuralgia.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  9. Mixed Reality Surgical Navigation System; Positional Accuracy Based on Food and Drug Administration Standard.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  10. Augmented reality-guided craniofacial and airway nerve block training for anesthesiology residents.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  11. Mixed Reality in the Operating Room: An Initial Use in Frontal Sinus Setback in Gender-affirming Facial Surgery.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  12. Optimizing the Workflow of Superficial Temporal Artery Mapping in Extracranial-Intracranial Bypass Surgery Using Mixed Reality: A Proof-of-Concept Study.

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  13. The Effect of AR in Patient Pre-operative Education

    U.S. National Library of Medicine - Accessed 2026-09-03

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

Research history

  1. K190764 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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