Radiology AI Directory

FDA-cleared profile

Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System

Philips Medical Systems Nederland B.V.

Authorized purpose: The Philips 1.5T and 3T MRI system family with release R12.3 supports broad diagnostic and interventional imaging and adds SmartSpeed Precise machine-learning reconstruction.

MRI 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: The Philips 1.5T and 3T MRI system family with release R12.3 supports broad diagnostic and interventional imaging and adds SmartSpeed Precise machine-learning reconstruction.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: The Philips 1.5T and 3T MRI system family with release R12.3 supports broad diagnostic and interventional imaging and adds SmartSpeed Precise machine-learning reconstruction.

Evidence takeaway

Evidence from the reviewed source record: K251397 reports nonclinical software, system, image-quality, and sample-image validation; no clinical study was required. Eight exact-identifier recall records concern MRE stiffness errors under specified reconstruction settings, not every scan or AI feature.

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
The Philips 1.5T and 3T MRI system family with release R12.3 supports broad diagnostic and interventional imaging and adds SmartSpeed Precise machine-learning reconstruction.
  • 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
Trained physicians.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact indication names trained physicians; it does not establish MRI technologists as the intended-user class.

Care setting and population
Hospital and outpatient MRI departments operating the cleared field strength, coils, protocols, and accessories.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Workflow role
MRI acquisition, reconstruction, review, and release-specific workflow support.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Required input
Patient MRI signal data acquired with supported coils and protocols.
  • 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.

Output and human action
This MR system enables trained physicians to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin. The systems can use combinations of images to produce physical parameters, and related derived images. Images, spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assist diagnosis and therapy planning.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The direct packet supports images, spectra, physical parameters, derived images, and measurements; the current reconstructed-series and workflow-results additions are not retained.

Limitations
Image appearance is determined by many different physical properties of the tissue and the anatomy, the MR scan technique applied, and presence of contrast agents. The use of contrast agents for diagnostic imaging applications should be performed consistent with the approved labeling for the contrast agent. The accuracy of determined physical parameters depends on system and scan parameters and must be controlled and validated by the clinical user. MR Interventional procedures, performed inside or adjacent to the Philips MR system, must be performed with MR Conditional or MR Safe instrumentation as selected and evaluated by the clinical user for use with the specific MR system configuration in the hospital. The appropriateness and use of information from a Philips MR system for a specific interventional procedure and specific MR system configuration must be validated by the clinical user.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

These are the packet's direct contrast, scan-parameter, instrumentation, and clinical-user validation boundaries; the current broad release and population limitation is not stated.

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
K251397
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
MRI
  • 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.

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
2025-06-04
  • 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
Scanner-console and DICOM workflow to PACS or downstream applications; validate worklist, identifiers, series labels, geometry, measurements, routing, and archive completeness.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Deployment and data flow
Installed MRI hardware and release-specific scanner software with licensed coils, sequences, and options.
  • FDA 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 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 qualified mri technologists and physicians trained in magnetic resonance imaging. 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 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 these product-specific limits: Field strength, coil, sequence, anatomy, population, and optional-feature limits vary by model and release; map the installed configuration to the exact clearance and labeling.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, and outputs to K251397 before acceptance.

exact submission · checked 2026-09-03

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

Source

Interoperability acceptance

Scanner-console and DICOM workflow to PACS or downstream applications; validate worklist, identifiers, series labels, geometry, measurements, routing, and archive completeness.

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. Field strength, coil, sequence, anatomy, population, and optional-feature limits vary by model and release; map the installed configuration to the exact clearance and labeling.

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 these product-specific limits: Field strength, coil, sequence, anatomy, population, and optional-feature limits vary by model and release; map the installed configuration to the exact clearance and labeling.

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. Candidate literature without exact product and version linkage is not shown as product evidence.

Evidence summary
K251397 reports nonclinical software, system, image-quality, and sample-image validation; no clinical study was required. Eight exact-identifier recall records concern MRE stiffness errors under specified reconstruction settings, not every scan or AI feature.
  • 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 acquisition, 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 acquisition, 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.

K251397 FDA performance package for Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System

  • DesignManufacturer nonclinical system, software, reconstruction, and sample-image verification
  • PopulationBroad diagnostic, interventional, and treatment-planning MRI applications
  • Scopeexact submission
  • Tested versionPhilips MR systems release R12.3
  • IndependenceSponsor or vendor study

K251397

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

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 2026-09-03

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 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
8 reviewed FDA recall records in the 2026-09-02 openFDA snapshot natively identify K251397. Confirm affected model, version, unit, correction, and current manufacturer instructions. FDA recall Z-1954-2026 affects a specified Philips MRI configuration with MR elastography. Certain reconstruction settings used with the Resoundant algorithm could produce stiffness errors because the default reconstruction voxel size was too small. FDA lists the recall as open and classified. FDA recall Z-1958-2026 affects a specified Philips MRI configuration with MR elastography. Certain reconstruction settings used with the Resoundant algorithm could produce stiffness errors because the default reconstruction voxel size was too small. FDA lists the recall as open and classified. FDA recall Z-1961-2026 affects a specified Philips MRI configuration with MR elastography. Certain reconstruction settings used with the Resoundant algorithm could produce stiffness errors because the default reconstruction voxel size was too small. FDA lists the recall as open and classified. FDA recall Z-1962-2026 affects a specified Philips MRI configuration with MR elastography. Certain reconstruction settings used with the Resoundant algorithm could produce stiffness errors because the default reconstruction voxel size was too small. FDA lists the recall as open and classified. FDA recall Z-1964-2026 affects a specified Philips MRI configuration with MR elastography. Certain reconstruction settings used with the Resoundant algorithm could produce stiffness errors because the default reconstruction voxel size was too small. FDA lists the recall as open and classified. FDA recall Z-1965-2026 affects a specified Philips MRI configuration with MR elastography. Certain reconstruction settings used with the Resoundant algorithm could produce stiffness errors because the default reconstruction voxel size was too small. FDA lists the recall as open and classified. FDA recall Z-1968-2026 affects a specified Philips MRI configuration with MR elastography. Certain reconstruction settings used with the Resoundant algorithm could produce stiffness errors because the default reconstruction voxel size was too small. FDA lists the recall as open and classified. FDA recall Z-1969-2026 affects a specified Philips MRI configuration with MR elastography. Certain reconstruction settings used with the Resoundant algorithm could produce stiffness errors because the default reconstruction voxel size was too small. FDA lists the recall as open and classified.
  • FDA source
  • Exact product version
  • Checked 2026-09-04

Each published event was manually matched to the exact FDA submission and affected product or version; a recall does not establish an AI-algorithm defect or current site exposure unless the event states that scope.

recall: Z-1954-2026

Open, Classified

2026-04-27

Exact native submission match, but each recall is model-specific and limited to MR elastography settings; confirm model, protocol correction, and software-upgrade status.

Source

recall: Z-1958-2026

Open, Classified

2026-04-27

Exact native submission match, but each recall is model-specific and limited to MR elastography settings; confirm model, protocol correction, and software-upgrade status.

Source

recall: Z-1961-2026

Open, Classified

2026-04-27

Exact native submission match, but each recall is model-specific and limited to MR elastography settings; confirm model, protocol correction, and software-upgrade status.

Source

recall: Z-1962-2026

Open, Classified

2026-04-27

Exact native submission match, but each recall is model-specific and limited to MR elastography settings; confirm model, protocol correction, and software-upgrade status.

Source

recall: Z-1964-2026

Open, Classified

2026-04-27

Exact native submission match, but each recall is model-specific and limited to MR elastography settings; confirm model, protocol correction, and software-upgrade status.

Source

recall: Z-1965-2026

Open, Classified

2026-04-27

Exact native submission match, but each recall is model-specific and limited to MR elastography settings; confirm model, protocol correction, and software-upgrade status.

Source

recall: Z-1968-2026

Open, Classified

2026-04-27

Exact native submission match, but each recall is model-specific and limited to MR elastography settings; confirm model, protocol correction, and software-upgrade status.

Source

recall: Z-1969-2026

Open, Classified

2026-04-27

Exact native submission match, but each recall is model-specific and limited to MR elastography settings; confirm model, protocol correction, and software-upgrade status.

Source

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
27Fields reviewed
11Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

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. 8 FDA recall candidates were manually reviewed: 8 published and 0 rejected as a neighboring or otherwise inapplicable version. Native FDA recall identifiers produced 8 postmarket candidate records; 8 have been reviewed (8 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, 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 K251397: Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System

    U.S. Food and Drug Administration - Published 2025-06-04 - Accessed 2026-09-19

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

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. FDA recall Z-1954-2026: Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (REF): 782166.

    U.S. Food and Drug Administration - Published 2026-04-27 - Accessed 2026-09-04

    Scope: postmarketSafety, affectedProduct, recallStatus, correctiveAction

  4. FDA recall Z-1958-2026: Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    U.S. Food and Drug Administration - Published 2026-04-27 - Accessed 2026-09-04

    Scope: postmarketSafety, affectedProduct, recallStatus, correctiveAction

  5. FDA recall Z-1961-2026: Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160.

    U.S. Food and Drug Administration - Published 2026-04-27 - Accessed 2026-09-04

    Scope: postmarketSafety, affectedProduct, recallStatus, correctiveAction

  6. FDA recall Z-1962-2026: Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF): 782137.

    U.S. Food and Drug Administration - Published 2026-04-27 - Accessed 2026-09-04

    Scope: postmarketSafety, affectedProduct, recallStatus, correctiveAction

  7. FDA recall Z-1964-2026: Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.

    U.S. Food and Drug Administration - Published 2026-04-27 - Accessed 2026-09-04

    Scope: postmarketSafety, affectedProduct, recallStatus, correctiveAction

  8. FDA recall Z-1965-2026: Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112.

    U.S. Food and Drug Administration - Published 2026-04-27 - Accessed 2026-09-04

    Scope: postmarketSafety, affectedProduct, recallStatus, correctiveAction

  9. FDA recall Z-1968-2026: Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.

    U.S. Food and Drug Administration - Published 2026-04-27 - Accessed 2026-09-04

    Scope: postmarketSafety, affectedProduct, recallStatus, correctiveAction

  10. FDA recall Z-1969-2026: Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.

    U.S. Food and Drug Administration - Published 2026-04-27 - Accessed 2026-09-04

    Scope: postmarketSafety, affectedProduct, recallStatus, correctiveAction

  11. PubMed biomedical literature index

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

    Scope: evidenceDiscovery

  12. ClinicalTrials.gov study registry

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

    Scope: evidenceDiscovery, studyStatus

  13. Medicare Coverage Database

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

    Scope: coverage, codingContext

  14. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

Research history

  1. K251397 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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