Radiology AI Directory

FDA-cleared profile

Tempus Pixel

Arterys, Inc.

Multimodality DICOM image management, quantitative analysis, optional cardiovascular MR mapping and flow analysis, and therapy-response lesion tracking for trained clinicians.

Quantification and segmentation
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

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
Multimodality DICOM image management, quantitative analysis, optional cardiovascular MR mapping and flow analysis, and therapy-response lesion tracking for trained clinicians.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Intended users
Trained healthcare professionals, including radiology and cardiovascular imaging users.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Care setting and population
Clinical imaging environments using PACS or scanner-originated studies.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Workflow role
Adjunct image viewer and analysis tool; the FDA labeling says it does not directly generate a diagnosis or finding.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Required input
DICOM and non-DICOM radiological images, including multi-slice and multi-phase CT, MR, ultrasound, x-ray and mammography studies; optional cardiovascular MR includes velocity-encoded data.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Output and human action
Cloud image display with 2D, 3D and MIP views, measurements, reports, secondary capture, optional T1/T2 and 4D-flow cardiovascular MR outputs, and lesion tracking or Lung-RADS reporting workflows.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Limitations
Requires trained healthcare professionals and user review; optional cardiovascular MR was tested at 1.5T and 3.0T; optional modules and third-party algorithms are not all part of this exact submission.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06

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
K252539
  • 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 2026-09-06
Anatomy
Multi-region
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06

The FDA intended use is multimodality rather than a single anatomic site.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-09-03
  • 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
FDA materials describe upload from PACS or scanner and report/secondary-capture workflows; the Tempus family material was readable during the Sept 7 review and describes PACS, EHR, worklist, notification and dictation integration, but does not establish the exact K252539 configuration. A later automated request returned HTTP 429, which is treated as rate limiting rather than absence of product information.
  • Public source
  • Product family
  • Checked 2026-09-07
Deployment and data flow
The reviewed FDA summary describes a completely hosted cloud application accessed through Chrome on standard computers and displays.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-07

The reviewed sources do not establish a current exact-release security attestation or contract scope.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-08-13

Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-08-13

Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.

Cloud delivery

The exact FDA summary describes a hosted application accessed through Chrome.

exact submission · checked 2026-09-06
Source

Family PACS and EHR workflow

Current Tempus Pixel family material describes PACS, EHR, worklist, notification and dictation integration; exact K252539 configuration is not established.

product family · checked 2026-09-07
Source

Image and report handling

FDA materials describe 2D/3D/MIP display, measurements, reports and secondary capture outputs.

exact submission · checked 2026-09-06
Source

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
FDA-reviewed non-clinical T1/T2 inline-map and workflow validation supports the exact release; the FDA summary states there was no clinical study for the modified device.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Reported sensitivity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

Reported specificity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

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

T1/T2 inline map validation

  • DesignNon-clinical comparative bench validation
  • Population30 cardiovascular MR series across manufacturer and scanner types, with four regions of interest per series
  • Scopeexact submission
  • Tested versionTempus Pixel release reviewed in K252539
  • Samplen=30
  • IndependenceSponsor or vendor study

K252539 FDA 510(k) summary

The FDA summary reports software verification and validation passed and states no clinical study was performed for the modified device.

Source

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 2026-09-07

No numeric price was published in the reviewed sources.

Reimbursement and coding
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.

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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

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

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.

Human reviewedStatus
2026-09-07Last searched
23Fields reviewed
11Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The stored candidate metadata contained empty PubMed and clinical-trial ID arrays; metadata was screened, not full-text or registry-reviewed. The stored recall candidate record was empty and no event 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, acr ai central product, vendor product page, vendor manual, peer reviewed publication, clinical trial registry, recall database, 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. K252539 FDA decision source

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

    Scope: regulatoryIdentity, purpose, modality, anatomy

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. Tempus Pixel model card (K252539)

    American College of Radiology - Published 2026-08-17 - Accessed 2026-09-01

    Scope: intendedUsers, careSetting, output, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities

  4. PubMed biomedical literature index

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

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

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

    Scope: evidenceDiscovery, studyStatus

  6. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

  7. FDA 510(k) decision record and summary reviewed for Tempus Pixel, K252539

    U.S. Food and Drug Administration - Published 2025-09-03 - Accessed 2026-09-06

    Scope: identity, intended_use, performance, limitations, implementation

  8. Medical Imaging Cloud AI for Radiology

    Arterys / Tempus - Accessed 2026-09-07

    Scope: product_family, cloud_access, PACS_EHR_workflow

  9. Tempus Pixel Therapy Response Evaluation

    Tempus - Accessed 2026-09-07

    Scope: product_family, lesion_tracking, PACS_EHR_integration

Research history

  1. K252539 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

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