Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems
K213583Philips Medical Systems Nederland B.V. · cleared 2022-05-16 · product code LNH · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“Philips Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. 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.”
source quote (p.8)
“The software R11 used on the proposed Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems has been modified to include the SmartSpeed AI feature combining the previously cleared and legally marketed feature Compressed-SENSE (K193215, 04/10/2020) with machine learning to allow for higher accelerations with equal or better image quality.”
source quote (p.8)
“Guidance for Industry and FDA Staff – Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (issued October 2, 2014 – document number 1825)”
Validation studies (2)
Standalone
sample size not stated
endpoints: pixel-wise comparison; comparable or better results; better alignment; does not negatively impact image quality measures when acquired with reduced scan time
standards: IEC60601-1 Edition 3, IEC60601-1-2 Edition 4, IEC60601-1-6 Edition 3, IEC62366-1 Edition 1, IEC60601-1-8 Edition 2, IEC60601-2-33 Edition 3, IEC 62304 Edition 1, NEMA MS-1 2008, NEMA MS-4 2010, NEMA MS-8 2008, NEMA PS 3.1-PS 3.20, ISO 14971 Edition 2, Device specific guidance document, entitled “Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices” (issued November 18, 2016 – document number 340), Guidance for Industry and FDA Staff – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 11, 2005 – document number 337), Guidance for Industry and FDA Staff – Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (issued October 2, 2014 – document number 1825)
Reader study (MRMC)
sample size not stated
endpoints: comparisons of SmartSpeed AI images acquired with shorter scan times and images without SmartSpeed AI acquired with longer scan times
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) K223458 (decision 2023-04-06) from Philips Medical Systems Nederland B.V. for a matching device line ("Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K223458
- 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).