Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems

K223458

Philips Medical Systems Nederland B.V. · cleared 2023-04-06 · product code LNH · Radiology

FDA 510(k) summary for Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems (K223458)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
2
Cited predicates
3
Performance observations
0
Product code
LNH
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.3)
“Philips Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Precise Image is a deep learning based reconstruction technique designed to increase signal-to-noise ratio (SNR), increase sharpness and decrease ringing artefacts from MR images.”
Algorithmdeep learning based reconstruction technique
source quote (p.5)
“Precise Image is a deep learning based reconstruction technique designed to increase signal-to-noise ratio (SNR), increase sharpness and decrease ringing artefacts from MR images.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated

standards: IEC60601-2-33 Ed. 3.2:2010 + Amd 1:2013 + Amd 2:2015, ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, IEC60601-1-2 Ed. 4.0:2014, IEC 60601-1-6 Ed. 3.1:2010 + Amd 1:2013, IEC 60601-1-8 Ed. 2.1:2006 + Amd 1:2012 (Ed.2.1), ISO 14971 Third Edition 2019, IEC 62366-1 Ed. 1.0:2015, IEC 62304 Ed. 1.1:2015

Reader study (MRMC)

sample size not stated

endpoints: signal-to-noise ratio (SNR); artifact level; sharpness; contrast-to-noise ratio (CNR); quality of the visualization of abnormalities and pathologies; sufficient quality for diagnostic purposes

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

25
recalls in product code, 24mo
530
MAUDE reports in code, 12mo
+6%
vs code's own 3-yr baseline
4
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K253648 (decision 2026-02-23) from Philips Medical Systems Nederland B.V. for a matching device line ("Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K253648

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K251397 (decision 2025-06-04) from Philips Medical Systems Nederland B.V. for a matching device line ("Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K251397

  • recall_reason_pattern

    Software/algorithm-related recall in product code LNH (Philips North America, initiated 2026-04-14): "The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction " Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98779

  • recall_reason_pattern

    Software/algorithm-related recall in product code LNH (Philips North America, initiated 2025-12-03): "The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS)." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98111

Recalls attributed to this device

  • Recall record explicitly lists K223458 · Philips North America · initiated 2026-04-14 · Open, Classified

    The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

    recall event 98779 (openFDA)

  • Recall record explicitly lists K223458 · Philips North America · initiated 2026-04-14 · Open, Classified

    The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

    recall event 98779 (openFDA)

  • Recall record explicitly lists K223458 · Philips North America · initiated 2026-04-14 · Open, Classified

    The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

    recall event 98779 (openFDA)

  • Recall record explicitly lists K223458 · Philips North America · initiated 2026-04-14 · Open, Classified

    The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

    recall event 98779 (openFDA)

  • Recall record explicitly lists K223458 · Philips North America · initiated 2026-04-14 · Open, Classified

    The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

    recall event 98779 (openFDA)

  • Recall record explicitly lists K223458 · Philips North America · initiated 2026-04-14 · Open, Classified

    The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

    recall event 98779 (openFDA)

  • Recall record explicitly lists K223458 · Philips North America · initiated 2026-04-14 · Open, Classified

    The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

    recall event 98779 (openFDA)

  • Recall record explicitly lists K223458 · Philips North America · initiated 2026-04-14 · Open, Classified

    The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

    recall event 98779 (openFDA)

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-08-26.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Related FDA clearances

More AI/ML devices under product code LNH

These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

S-scan Open (100001800)

K260746

Esaote, S.p.A.

cleared 2026-03-27

Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR

K253625

Canon Medical Systems Corporation

cleared 2026-03-27

LiverMultiScan (v6.0)

K253413

Perspectum, Ltd.

cleared 2026-03-09

Magnifico Open (100009900)

K251901

Esaote, S.p.A.

cleared 2026-03-05

MAGNETOM Flow.Ace; MAGNETOM Flow.Plus

K260265

Siemens Shenzhen Magnetic Resonance , Ltd.

cleared 2026-02-23

Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades

K253648

Philips Medical Systems Nederland B.V.

cleared 2026-02-23

SIGNA™ Bolt

K253780

Ge Medical Systems, LLC

cleared 2026-02-06

SIGNA™ Sprint Select

K253779

Ge Medical Systems, LLC

cleared 2026-02-05

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K223458