Radiology AI Directory

FDA-cleared profile

Aurora

GE Medical Systems Israel

Aurora is a SPECT/CT system for nuclear-medicine uptake imaging, standalone CT, anatomical localization, attenuation correction, diagnosis, staging, therapy planning, guidance, and monitoring. K251153 adds deep-learning kidney segmentation to dynamic renal scintigraphy.

Quantification and segmentationNuclear medicine
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
Aurora is a SPECT/CT system for nuclear-medicine uptake imaging, standalone CT, anatomical localization, attenuation correction, diagnosis, staging, therapy planning, guidance, and monitoring. K251153 adds deep-learning kidney segmentation to dynamic renal scintigraphy.
FDA source Exact FDA submission Checked 2026-09-04

Added in P2 round17 from the exact FDA decision material; later product-family claims remain separate.

Intended users
Qualified nuclear-medicine physicians, radiologists, technologists, and other trained healthcare professionals.
FDA source Exact FDA submission Checked 2026-09-03
Care setting and population
Hospital and outpatient nuclear-medicine departments.
FDA source Exact FDA submission Checked 2026-09-03
Workflow role
Planar nuclear medicine, SPECT/CT acquisition and analysis, with optional reviewed kidney contours for real-time time-activity curves.
Public source Exact FDA submission Checked 2026-09-03
Required input
Nuclear-medicine acquisition data and CT data; dynamic renal studies for automatic kidney segmentation.
FDA source Exact FDA submission Checked 2026-09-03
Output and human action
Planar, SPECT, CT, fused images, uptake quantification, time-activity curves, and reviewed kidney contours.
FDA source Exact FDA submission Checked 2026-09-03
Limitations
Automatic kidney contours must be confirmed by the user. The 70-exam evaluation reported success against predefined criteria but the public summary does not disclose the achieved mean Dice value.
FDA source Exact FDA submission Checked 2026-09-03

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
K251153
FDA source Exact FDA submission Checked 2026-08-31
Modality
PET/SPECT/Nuclear Medicine
FDA source Exact FDA submission Checked 2026-09-03
Anatomy
Multi-region
FDA source Exact FDA submission Checked 2026-09-03
Clearance type
510(k)
FDA source Exact FDA submission Checked 2026-08-31
Decision date
2025-06-12
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
Integrated acquisition and operator console with DICOM imaging workflow; verify quantitative export and renal-analysis routing locally.
Public source Exact FDA submission Checked 2026-09-03
Deployment and data flow
Installed SPECT/CT system with console-integrated locked kidney-segmentation algorithm.
Public source Exact FDA submission Checked 2026-09-03
Security and privacy
Vendor documentation pending
Vendor confirmation Exact FDA submission Checked 2026-09-03

Public materials reviewed for this batch do not establish the complete security posture for the exact release. Request data-flow, identity, audit, encryption, retention, support-access, vulnerability-management, backup, and incident-response evidence.

Training and support
Only qualified nuclear-medicine physicians, radiologists, technologists, and other trained healthcare professionals. should operate or interpret the system. 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 and model 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 the limits that matter for this product: Automatic kidney contours must be confirmed by the user. The 70-exam evaluation reported success against predefined criteria but the public summary does not disclose the achieved mean Dice value.
Public source Exact FDA submission Checked 2026-09-03

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, and outputs to K251153 before acceptance.

exact submission · checked 2026-09-03

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

Source

Interoperability acceptance

Integrated acquisition and operator console with DICOM imaging workflow; verify quantitative export and renal-analysis routing locally.

exact submission · checked 2026-09-03

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.

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. Automatic kidney contours must be confirmed by the user. The 70-exam evaluation reported success against predefined criteria but the public summary does not disclose the achieved mean Dice value.

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

Vendor productivity claims are scenario inputs, not guaranteed local savings.

Source

Lifecycle monitoring

Monitor by exact hardware, software and model 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 the limits that matter for this product: Automatic kidney contours must be confirmed by the user. The 70-exam evaluation reported success against predefined criteria but the public summary does not disclose the achieved mean Dice value.

exact submission · checked 2026-09-03

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.

Source

Evidence

Performance evidence

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

Evidence summary
Exact-submission testing evaluated 70 independent dynamic renal studies from three hospitals and included a three-reader U.S. clinical-utility assessment. The summary reports an average Dice score above the predefined criterion and acceptable utility with minimal interaction without publishing the numeric score.
Public 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 applicable endpoint for this acquisition, reconstruction, segmentation, planning, guidance, or dose-delivery function. Use the task-specific endpoints and tested population reported below.

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

Specificity is not the primary applicable endpoint for this acquisition, reconstruction, segmentation, planning, guidance, or dose-delivery function. Use the task-specific endpoints and tested population reported below.

Qualified clinical readers

3 readers

Four-point Likert assessment of kidney-contour utility and user interaction in Aurora.

Tested version: Aurora with DL Automatic Kidney Segmentation cleared in K251153
Source

K251153 FDA performance package for Aurora

Independent-data bench segmentation comparison plus three-reader clinical-utility review · 70 dynamic renal scintigraphy examinations from two U.S. hospitals and one European hospital

exact submission · Tested version: Aurora with DL Automatic Kidney Segmentation cleared in K251153 · n=70 · 3 sites · Sponsor or vendor study

K251153

Manufacturer evidence submitted for substantial equivalence; local clinical, technical, 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
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, enabled features, 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 device within the applicable imaging 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.

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 K251153 by exact submission identifier.
Public source Exact FDA submission Checked 2026-09-03

A zero-result exact-identifier search does not prove that no recall, correction, adverse-event report, or product-family safety signal 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
2026-09-04Last searched
26Fields reviewed
10Source classes checked
20Reviewed PubMed leads
10Reviewed trial leads
0Unreviewed FDA recall leads

Twenty PubMed records and ten trial records were screened. The results concern Aurora kinases, unrelated named programs, or other imaging and do not identify the GE Aurora SPECT/CT K251153 release. No evidence was promoted, and all 30 candidates remain quarantined. The current discovery snapshot contains 20 PubMed and 10 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, reimbursement policy, fda device recall, fda decision material, literature index, trial registry, pubmed, clinical trials, openfda device recall

Sources

Source ledger

Sources accessed through 2026-09-04.

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Modality
PET/SPECT/Nuclear Medicine
Anatomy
Multi-region
Decision
2024-08-30
Quantification and segmentationNuclear medicine