Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems
K223458Philips Medical Systems Nederland B.V. · cleared 2023-04-06 · product code LNH · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“The proposed Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems R12 are 60 cm and 70 cm bore 1.5 and 3.0 Tesla (1.5T and 3.0T) Magnetic Resonance Diagnostic Devices, hereafter to be known as Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems. 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.”
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.”
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
- 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
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
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).