Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems

K213583

Philips Medical Systems Nederland B.V. · cleared 2022-05-16 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.6)
“The proposed Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems R11.0 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 Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems.”
AlgorithmSmartSpeed AI feature combining the previously cleared and legally marketed feature Compressed-SENSE with machine learning to allow for higher accelerations with equal or better image quality.
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.”
Adaptive (vs locked)No
PCCPFDA source did not state this
Cybersecurity addressedYes
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)

Bench

sample size not stated

endpoints: confirm that SmartSpeed AI does provide comparable or better results than the data reconstructed without SmartSpeed AI; SmartSpeed AI showed better alignment with the ground truth data for high acceleration factors and low SNR levels compared to the data reconstructed without SmartSpeed AI

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, Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices, Guidance for Industry and FDA Staff – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Guidance for Industry and FDA Staff – Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Guidance for Industry and FDA Staff – Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and FDA Staff – Use of International Standard ISO 10993-1, “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process”, Guidance for Industry and FDA Staff – Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices, Guidance for Industry and FDA Staff – Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices

Reader study (MRMC)

sample size not stated

endpoints: confirm that SmartSpeed AI does not negatively impact image quality measures when acquired with reduced scan time; provides images with equivalent or better image quality

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, Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices, Guidance for Industry and FDA Staff – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Guidance for Industry and FDA Staff – Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Guidance for Industry and FDA Staff – Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and FDA Staff – Use of International Standard ISO 10993-1, “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process”, Guidance for Industry and FDA Staff – Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices, Guidance for Industry and FDA Staff – Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices

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

100
recalls in product code, 24mo
510
MAUDE reports in code, 12mo
+5%
vs code's own 3-yr baseline
3
drift signals on this device
  • 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

Recalls attributed to this device

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · initiated 2025-06-20

    GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

    recall event 97187 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · initiated 2025-06-20

    GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

    recall event 97187 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · initiated 2025-06-20

    GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

    recall event 97187 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · initiated 2025-06-20

    GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

    recall event 97187 (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 2026-07-08.

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).

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.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K213583