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.

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 trained clinical user can adjust the MR scan parameters to customize image appearance, accelerate image acquisition, and synchronize with the patient's breathing or cardiac cycle. 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. The accuracy of determined physical parameters depends on system and scan parameters and must be controlled and validated by the clinical user.

In addition, the Philips MR systems provide imaging capabilities, such as MR fluoroscopy, to guide and evaluate interventional and minimally invasive procedures in the head, body and extremities.

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.

Device Description

The subject Achieva, Intera, Ingenia 1.5T, Ingenia 3.0T, Ingenia 1.5T CX, Ingenia 3.0T CX, Ingenia Elition S, Ingenia Elition X, Ingenia Ambition S, Ingenia Ambition X and MR 5300 MR Systems are 60 cm and 70 cm bore 1.5 and 3.0 Tesla (1.5T and 3.0T) Magnetic Resonance Diagnostic Devices.
In this 510(k) submission, Philips Medical Systems Netherlands B.V. will be addressing the following software changes for the subject device since the last 510(k) submission (primary predicate device (K212673, 11/19/2021), secondary predicate device (K193215, 04/10/2020)):

Software functionality that allows early detection of severe gradient malfunctions. The system is locked for scanning if a malfunction is detected.
Smoke detector software support extension from Ingenia Elition S and X to all other 70cm bore systems
SENSE XL Torso Coil workflow extensions to guide the operator on safe usage of the SENSE XL Torso Coil and monitoring of the SENSE XL Torso Coil temperature

The subject Achieva, Intera, Ingenia 1.5T, Ingenia 3.0T, Ingenia 1.5T CX, Ingenia 3.0T CX, Ingenia Elition S, Ingenia Elition X, Ingenia Ambition S, Ingenia Ambition X and MR 5300 MR Systems are intended to be marketed with the same pulse sequences and coils that are previously cleared by FDA. The accessories to be used with the subject devices have not changed compared to the predicate device.
When Philips MRI system is used in combination with the Philips MR-RT or MR-OR solutions, the user is referred to the dedicated MR-RT and MR-OR Instructions for Use for information on additional accessories that may apply.

AI/ML Overview

The provided FDA 510(k) clearance letter and its associated 510(k) Summary for Philips MR Systems (K251808) DO NOT contain the detailed information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the manner requested.

This submission is a Special 510(k), which is used for modifications to a manufacturer's own legally marketed device where the modified device is still substantially equivalent to the cleared device, and the modifications do not raise new questions of safety and effectiveness. This type of submission often relies heavily on risk management and performance testing to demonstrate that the changes have not degraded the safety or effectiveness of the device.

The document primarily focuses on software changes related to safety-critical functions (gradient malfunction detection, smoke detector interlock, SENSE XL Torso Coil temperature monitoring) and asserts substantial equivalence to existing predicate devices.

Here's why the requested information cannot be fully extracted and what can be inferred:

Summary of Information NOT Present in the Document:

Detailed Acceptance Criteria Table with Performance Data: The document states that "The verification and/or validation test results demonstrate that the subject... MR Systems meet the acceptance criteria and are adequate for the intended use" (Page 8), but it does not provide a specific table of these acceptance criteria nor the numerical performance data for the device against them. The information provided about the software changes focuses on their functionality and equivalence rather than quantitative performance metrics (e.g., specific thresholds for gradient malfunction detection sensitivity/specificity, or precise temperature monitoring accuracy).
Sample Size for Test Set and Data Provenance: No specific test set sample sizes (e.g., number of patients, number of scans) are mentioned. The testing described is "Non-Clinical verification and validation tests," implying it's not based on patient data in the typical sense for clinical performance.
Number of Experts and Qualifications for Ground Truth: Since no clinical data or diagnostic performance studies are described (only non-clinical V&V), there's no mention of experts establishing ground truth for a test set.
Adjudication Method for Test Set: Not applicable as no clinical study with expert reads is described.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned as no clinical study evaluating human reader performance is described.
Standalone (Algorithm Only) Performance: While the software features operate automatically, no quantitative standalone performance data (e.g., TPR, FPR for malfunction detection) is provided. The focus is on the functionality of the safety mechanisms (e.g., "system is locked," "enforces a cool down period").
Type of Ground Truth Used: For the safety software functions, the "ground truth" would likely be derived from engineering specifications, simulated fault conditions, or direct sensor readings validated against known physical parameters, rather than expert consensus on medical images or pathology. The document hints at this by stating "verification and/or validation test results demonstrate that the subject... meet the acceptance criteria and are adequate for the intended use."
Sample Size for Training Set & Ground Truth Establishment for Training Set: Since these are modifications to existing, cleared devices, and the described changes are primarily safety and workflow enhancements, it's unlikely that new deep learning models requiring large imaging training sets were developed for these specific features. If machine learning was involved in the gradient malfunction detection, the specific training methodology is not disclosed. The document implies engineering-based verification and validation rather than large-scale data-driven model training.

Information that CAN be Inferred or Directly Stated:

Study Type: Non-clinical verification and validation tests, adhering to recognized international and FDA-recognized consensus standards (e.g., IEC 60601-1-6 for usability, IEC 62304 for software lifecycle, ISO 14971 for risk management).
Overall Conclusion: The non-clinical testing demonstrates that the modified MR Systems "meet the acceptance criteria and are adequate for the intended use" and that "all risks are sufficiently mitigated, that no new risks are introduced, and that the overall residual risks are acceptable." This leads to the conclusion of substantial equivalence.
Basis for Ground Truth (Implied): For the safety features, the "ground truth" is established by engineering specifications, simulated fault conditions, and internal testing to ensure the alarm/lockout mechanisms activate correctly under defined hazardous conditions and that the temperature monitoring is accurate.
Key Software Changes and Their Demonstrated Functionality:
- Severe Gradient Malfunction Detection: Modifies the system to lock when the frequency of gradient amplifier errors exceeds predefined thresholds, preventing severe malfunctions. The previous system only aborted individual errors and allowed continuation. The "study" here would be demonstrating that the system properly locks when these new thresholds are met and does not falsely lock otherwise.
- Smoke Detector Software Support Extension: Extends existing 60cm MR System smoke detector interlock software to 70cm MR Systems. The "study" would show that the same logic and safety performance are maintained on the new platform.
- SENSE XL Torso Coil Workflow Extensions: Software now enforces a cool-down period for the coil and guides the operator on temperature management. The "study" likely involved testing the logic of the cool-down enforcement and the accuracy/timing of the temperature warnings.

Based on the provided document, here's the most that can be extracted and inferred about the acceptance criteria and studies:

Device: Philips Achieva, Intera, Ingenia 1.5T, Ingenia 3.0T, Ingenia 1.5T CX, Ingenia 3.0T CX, Ingenia Elition S, Ingenia Elition X, Ingenia Ambition S, Ingenia Ambition X and MR 5300 MR Systems (software modifications).

Purpose of the Study: To demonstrate that software changes implemented for gradient malfunction detection, smoke detector interlock extension, and SENSE XL Torso Coil temperature monitoring do not raise new questions of safety and effectiveness and that the modified devices remain substantially equivalent to their predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Feature/Acceptance Criteria Category	Acceptance Criteria (Inferred from document)	Reported Device Performance (Inferred from document)
Severe Gradient Malfunction Detection	Software must accurately detect gradient amplifier error frequencies exceeding predefined safety thresholds.	The newly added functionality successfully detects when error frequency goes beyond predefined thresholds and preventively locks the MR Systems to avoid severe gradient malfunction.
	Software must prevent scanning/lock the system when thresholds are exceeded.	The MR Systems are preventively locked when critical thresholds are reached.
	Software must not unduly interfere with normal operation or cause false locks.	Functions similarly to the predicate in handling individual errors; additions do not impact intended use or raise new safety questions. Implies no undue false positives.
Smoke Detector Interlock Software	Smoke detector interlock software functionality from 60cm systems must be correctly implemented and perform identically on 70cm MR Systems.	The implementation of the Smoke Detector Interlock software in the 70cm MR Systems is the same compared to the predicate device for 60cm MR Systems; the technology is consistent.
	The system must be locked for scanning if a malfunction is detected (consistent with predicate).	As with the predicate, the system is locked for scanning if a malfunction is detected. Performance maintained across MR System types.
SENSE XL Torso Coil Workflow Extensions	Software must accurately track coil temperature during usage.	Temperature information is used to guide the operator.
	Software must enforce a cool-down period when temperature reaches predefined acceptable levels for the next examination or during examination.	The MR System software enforces a cool down period for the coil when temperature reaches a level that would go beyond an acceptable level in the next examination.
	Software must provide adequate warnings/guidance to the operator regarding coil temperature to ensure safe usage.	Temperature information is used to guide the operator, suggesting stopping examination and enforcing cool down to enable staying within acceptable temperature limits.
Overall Safety and Effectiveness	Compliance with relevant international and FDA-recognized consensus standards (e.g., IEC 60601-1-6, IEC 62304, ISO 14971, ISO 15223-1, ISO 20417).	Non-clinical performance testing demonstrates compliance with listed standards.
	All identified risks must be sufficiently mitigated.	Risk management activities show that all risks are sufficiently mitigated.
	No new risks introduced.	No new risks are introduced.
	Overall residual risks are acceptable.	The overall residual risks are acceptable.

2. Sample Size Used for the Test Set and Data Provenance:
The document states "Non-Clinical verification and validation tests have been performed." This implies engineering-level testing rather than patient-based clinical studies. No specific sample sizes (e.g., number of scan instances, number of patients) are provided. The data provenance is internal Philips testing, likely performed in the Netherlands (Philips Medical Systems Nederland B.V.). It is retrospective in the sense that it evaluates modifications to existing systems.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. Ground truth for these safety software functions is based on engineering specifications and direct measurement/simulation of system states and physical parameters (e.g., gradient performance, temperature, smoke detection), not on expert interpretations of medical images.

4. Adjudication Method for the Test Set:
Not applicable. There is no mention of human readers or adjudication processes for clinical image interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. The nature of these software modifications (safety and workflow enhancements) does not typically necessitate such a study for 510(k) clearance, especially in a Special 510(k). The document explicitly states "the indications for use remain unchanged and there were no technological characteristics relative to the predicate device that would require clinical testing."

6. If a Standalone (Algorithm Only) Performance was done:
Yes, in the sense that the software features (e.g., gradient malfunction detection, temperature monitoring logic) are algorithms operating on system data. However, quantitative performance metrics (e.g., sensitivity, specificity, accuracy) for these algorithms are not explicitly provided in the summary. The "performance" described is functional—that the system does lock, does enforce cool-downs, etc., when conditions are met.

7. The Type of Ground Truth Used:
For the software changes described, the ground truth is primarily based on:
* Engineering Specifications: Defining thresholds for gradient errors, acceptable temperature ranges for the coil.
* Simulated Fault Conditions: Testing whether the gradient malfunction detection activates correctly under controlled, simulated error rates or conditions.
* Direct Physical Measurements: Verifying the accuracy of temperature sensors and the initiation of cool-down periods.
* Compliance with Standards: Ensuring the robust implementation of software safety features as per recognized industry standards.

8. The Sample Size for the Training Set:
The document does not specify a training set sample size. Given the nature of the software changes (safety logic and workflow enhancements) and this being a Special 510(k), it is unlikely to involve large-scale machine learning model training on medical image datasets. If any internal parameters were 'trained' (e.g., for optimal gradient error thresholds), the details are not disclosed.

9. How the Ground Truth for the Training Set Was Established:
Not explicitly stated. If there were any trainable parameters for the safety functions, the ground truth would have been established via engineering analysis, simulation, and empirical testing to define the optimal setpoints for safety interlocks and warnings.

Summary

FDA 510(k) Clearance Letter - Philips MR Systems

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

July 11, 2025

Philips Medical Systems Nederland B.V.
Mehmet Caner Cagdanlioglu
Regulatory Affairs Manager
Veenpluis 6
Best, 5684 PC
Netherlands

Re: K251808

Trade/Device Name: Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR Systems

Regulation Number: 21 CFR 892.1000
Regulation Name: Magnetic Resonance Diagnostic Device
Regulatory Class: Class II
Product Code: LNH, LNI
Dated: June 12, 2025
Received: June 12, 2025

Dear Mehmet Caner Cagdanlioglu:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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K251808 - Mehmet Caner Cagdanlioglu
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K251808 - Mehmet Caner Cagdanlioglu
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ningzhi Li -S Digitally signed by Ningzhi Li -S

for
Daniel M. Krainak, Ph.D.
Assistant Director
DHT8C: Division of Radiological Imaging and Radiation Therapy Devices
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

Indications for Use

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.
K251808

Please provide the device trade name(s).

Achieva, Intera, Ingenia 1.5T, Ingenia 3.0T, Ingenia 1.5T CX, Ingenia 3.0T CX, Ingenia Elition S, Ingenia Elition X, Ingenia Ambition S, Ingenia Ambition X and MR 5300 MR Systems

Please provide your Indications for Use below.

Indications for Use:

Philips Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.

The trained clinical user can adjust the MR scan parameters to customize image appearance, accelerate image acquisition, and synchronize with the patient's breathing or cardiac cycle.

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. The accuracy of determined physical parameters depends on system and scan parameters and must be controlled and validated by the clinical user.

In addition, the Philips MR systems provide imaging capabilities, such as MR fluoroscopy, to guide and evaluate interventional and minimally invasive procedures in the head, body and extremities.

Please select the types of uses (select one or both, as applicable).
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

Achieva, Intera, Ingenia 1.5T, Ingenia 3.0T, Ingenia 1.5T CX, Ingenia 3.0T CX, Ingenia Elition S,
Page 9 of 30

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Philips Medical Systems Nederland B.V.

Magnetic Resonance Imaging

1 of 8

Premarket Notification [510(k)] Submission

Philips Medical Systems Nederland B.V.

510(k) Summary K251808

The 510(k) Summary was prepared in accordance with 21 CFR §807.92(c).

Preparation date: July 11, 2025

510(k) Owner: Philips Medical Systems Nederland B.V.
Veenpluis 6, 5684 PC, Best, The Netherlands
Establishment Registration Number: 3003768277

Contact person(s):

Mehmet Caner Cagdanlioglu (primary)
Regulatory Affairs Manager
Phone: +31 634590388
E-mail: mehmetcaner.cagdanlioglu@philips.com
Leo Louis (secondary)
Director Regulatory Affairs
Phone: +31 687945888
E-mail: Leo.Louis@Philips.com

Device Name: Achieva, Intera, Ingenia 1.5T, Ingenia 3.0T, Ingenia 1.5T CX, Ingenia 3.0T CX, Ingenia Elition S, Ingenia Elition X, Ingenia Ambition S, Ingenia Ambition X and MR 5300 MR Systems

Classification:

Classification Name: Magnetic Resonance Diagnostic Device (MRDD)
Regulation Number: 21 CFR 892.1000
Review Panel: 90-Radiology
Device Class: Class II
Primary Product Code: LNH
Secondary Product Code: LNI

Primary Predicate Device:

Trade Name: MR 5300 MR Systems
510(k) Clearance: K212673
Manufacturer: Philips Medical Systems Nederland B.V.
Classification Name: Magnetic Resonance Diagnostic Device (MRDD)
Regulation Number: 21 CFR 892.1000

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Philips Medical Systems Nederland B.V.

Magnetic Resonance Imaging

2 of 8

Premarket Notification [510(k)] Submission

Philips Medical Systems Nederland B.V.

Device Class: Class II
Primary Product Code: LNH
Secondary Product Code: LNI

Secondary Predicate Device:

Trade Name: Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems
510(k) Clearance: K193215
Manufacturer: Philips Medical Systems Nederland B.V.
Classification Name: Magnetic Resonance Diagnostic Device (MRDD)
Review Panel: 90-Radiology
Regulation Number: 21 CFR 892.1000
Device Class: Class II
Primary Product Code: LNH
Secondary Product Code: LNI

The primary and secondary predicate device are hereafter called "predicate devices" when intended to be used together.

Device description

In this 510(k) submission, Philips Medical Systems Netherlands B.V. will be addressing the following software changes for the subject device since the last 510(k) submission (primary predicate device (K212673, 11/19/2021), secondary predicate device (K193215, 04/10/2020)):

Software functionality that allows early detection of severe gradient malfunctions. The system is locked for scanning if a malfunction is detected.
Smoke detector software support extension from Ingenia Elition S and X to all other 70cm bore systems
SENSE XL Torso Coil workflow extensions to guide the operator on safe usage of the SENSE XL Torso Coil and monitoring of the SENSE XL Torso Coil temperature

The accessories to be used with the subject Achieva, Intera, Ingenia 1.5T, Ingenia 3.0T, Ingenia 1.5T CX, Ingenia 3.0T CX, Ingenia Elition S, Ingenia Elition X, Ingenia Ambition S, Ingenia

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Philips Medical Systems Nederland B.V.

Magnetic Resonance Imaging

3 of 8

Premarket Notification [510(k)] Submission

Philips Medical Systems Nederland B.V.

Ambition X and MR 5300 MR Systems have not changed compared to the predicate device and can be found in the Instructions for Use accompanying the device.

When Philips MRI system is used in combination with the Philips MR-RT or MR-OR solutions, the user is referred to the dedicated MR-RT and MR-OR Instructions for Use for information on additional accessories that may apply.

Indications for use

The indications for Use statement provided below for the subject Achieva, Intera, Ingenia 1.5T, Ingenia 3.0T, Ingenia 1.5T CX, Ingenia 3.0T CX, Ingenia Elition S, Ingenia Elition X, Ingenia Ambition S, Ingenia Ambition X and MR 5300 MR Systems is identical to the predicate devices. The intended use is also not impacted by the introduction of software changes as described in section Device Description.

Philips Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.

In addition, the Philips MR systems provide imaging capabilities, such as MR fluoroscopy, to guide and evaluate interventional and minimally invasive procedures in the head, body and extremities.

Design Features/Fundamental Scientific Technology:

Same as the predicate device, the subject Achieva, Intera, Ingenia 1.5T, Ingenia 3.0T, Ingenia 1.5T CX, Ingenia 3.0T CX, Ingenia Elition S, Ingenia Elition X, Ingenia Ambition S, Ingenia Ambition X and MR 5300 MR Systems is based on the principle that certain atomic nuclei present in the human body will emit a weak relaxation signal when placed in a strong magnetic field and excited by a radio signal at the precession frequency. The emitted relaxation signals are analyzed by the system and a computed image reconstruction is displayed on a video screen.

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Philips Medical Systems Nederland B.V.

Magnetic Resonance Imaging

Special 510(k)

4 of 8

Premarket Notification [510(k)] Submission

Philips Medical Systems Nederland B.V.

The principal technological components (magnet, transmit body coil, gradient coil, gradient amplifier, RF amplifier and patient support) of the subject Achieva, Intera, Ingenia 1.5T, Ingenia 3.0T, Ingenia 1.5T CX, Ingenia 3.0T CX, Ingenia Elition S, Ingenia Elition X, Ingenia Ambition S, Ingenia Ambition X and MR 5300 MR Systems is unchanged compared to predicate device.

Summary of Non‐Clinical Performance Data:

Non-clinical performance testing has been performed on the subject Achieva, Intera, Ingenia 1.5T, Ingenia 3.0T, Ingenia 1.5T CX, Ingenia 3.0T CX, Ingenia Elition S, Ingenia Elition X, Ingenia Ambition S, Ingenia Ambition X and MR 5300 MR Systems and demonstrates compliance with following international and FDA-recognized consensus standards:

Recognition Number	Standard Number and Date	Standard Name
5-132	IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION	Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
13-79	ANSI AAMI IEC 62304:2006/A1:2016	Medical device software - Software life cycle processes [Including Amendment 1 (2016)]
5-129	ANSI AAMI IEC 62366-1:2015+AMD1:2020 (Consolidated Text)	Medical devices Part 1: Application of usability engineering to medical devices including Amendment 1
5-125	ANSI AAMI ISO 14971: 2019	Medical devices – Application of risk management to medical devices.
5-134	ISO 15223-1:2021, 15223-1 Fourth Edition 2021-07	Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
5-135	ISO 20417 First Edition 2021-04 Corrected version 2021-12	Medical devices - Information to be supplied by the manufacturer

Non-Clinical verification and validation tests have been performed with regards to the intended use, the technical claims, the requirement specifications and the risk management results.

The verification and/or validation test results demonstrate that the subject Achieva, Intera, Ingenia 1.5T, Ingenia 3.0T, Ingenia 1.5T CX, Ingenia 3.0T CX, Ingenia Elition S, Ingenia Elition X, Ingenia Ambition S, Ingenia Ambition X and MR 5300 MR Systems meet the acceptance criteria and are adequate for the intended use.

The risk management activities show that all risks are sufficiently mitigated, that no new risks are introduced, and that the overall residual risks are acceptable.

Therefore, the subject Achieva, Intera, Ingenia 1.5T, Ingenia 3.0T, Ingenia 1.5T CX, Ingenia 3.0T CX, Ingenia Elition S, Ingenia Elition X, Ingenia Ambition S, Ingenia Ambition X and MR 5300 MR Systems are substantially equivalent to the legally marketed predicate devices in terms of safety and effectiveness.

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Philips Medical Systems Nederland B.V.

Magnetic Resonance Imaging

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Premarket Notification [510(k)] Submission

Philips Medical Systems Nederland B.V.

Summary of Clinical Data:

With the subject Achieva, Intera, Ingenia 1.5T, Ingenia 3.0T, Ingenia 1.5T CX, Ingenia 3.0T CX, Ingenia Elition S, Ingenia Elition X, Ingenia Ambition S, Ingenia Ambition X and MR 5300 MR Systems, the indications for use remain unchanged and there were no technological characteristics relative to the predicate device that would require clinical testing.

Substantial Equivalence:

Providing cross-sectional images based on the magnetic resonance phenomenon
Interpretation of the images is the responsibility of trained physicians
Images can be used for interventional and treatment planning purposes

The table below provides a comparison overview between the subject and predicate device for the software feature changes together with a rationale for why the differences do not raise different questions of safety and effectiveness and a conclusion on substantial equivalence.

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Magnetic Resonance Imaging

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Premarket Notification [510(k)] Submission

Philips Medical Systems Nederland B.V.

Table Technological characteristics comparison between subject and predicate device for software changes

Primary Predicate device (K212673, November 19, 2021) and Secondary Predicate Device (K193215, April 10, 2020)	Subject device	Conclusion on substantial equivalence
Smoke Detector Interlock
• Smoke Detector Interlock software for 60cm MR Systems.• The Smoke Detector Interlock reduced the risk of fire against abnormal use by ensuring that it is only possible to resume scanning after a Field Service Engineer has confirmed that no hazardous situation exists anymore.• The IfU (Instructions for Use) and UI have been updated for clarity with improved instructions to the user in case smoke is detected.• The PD-Break Heat Detector further reduced the risk to ensure that the system does not allow scanning before even smoke occurs.Note: The same smoke detector Interlock software technology has been implemented in the following reference devices: K230972 and K232030.	SimilarThe Smoke Detector Interlock software is implemented on 70cm MR Systems.	EquivalentThe implementation of the Smoke Detector Interlock software in the 70cm MR Systems of the subject device is the same compared to the predicate device for 60cm MR Systems. The difference between the 60cm and 70cm MR Systems does not raise any new questions regarding safety and effectiveness as the smoke detector technology is the same in both devices.
Severe Gradient Malfunction Detection
The MR System aborts on individual errors from the gradient amplifier and will reset and allow customer to continue.	SimilarMR System aborts individual errors from the gradient amplifier and will reset and allow customers to continue. The newly added additional check via the severe	EquivalentSimilar as the predicate device, the subject device aborts individual errors from the gradient amplifier and will reset and allow customers to continue. The additions in the subject device do not impact the intended use of the

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Table Technological characteristics comparison between subject and predicate device for software changes

Primary Predicate device (K212673, November 19, 2021) and Secondary Predicate Device (K193215, April 10, 2020)	Subject device	Conclusion on substantial equivalence
	gradient malfunction detection functionality will lock the subject device. When the frequency of occurrence of errors from this subset goes beyond predefined thresholds, then the MR Systems will be preventively locked to avoid severe gradient malfunction to occur.	device, nor does it raise any new questions of safety and effectiveness.
SENSE XL Torso Coil
Before and during the examinations, the MR System software does not warn the operator upfront and does not keep track of the SENSE XL Torso Coil temperature during usage.	SimilarThe MR System software enforces a cool down period for the coil when the temperature reaches a level that would go beyond an acceptable level in the next examination.In addition, the temperature information is used to guide the operator suggesting it is advised to stop the examination and enforce cool down to enable the operator to stay within acceptable temperature limits during an examination.	EquivalentThe implementation of additional operator guidance on the usage of the SENSE XL Torso coil and monitoring of the temperature does not impact the intended use of the device, nor does it raise any new questions of safety and effectiveness.

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Premarket Notification [510(k)] Submission

Philips Medical Systems Nederland B.V.

Based on the comparison described above Philips Medical Systems Nederland B.V. believes that the subject device is substantially equivalent to the predicate devices in terms of:

Intended Use / Indications for Use,
Technological characteristics,
Safety and effectiveness.

Conclusion:

The subject Achieva, Intera, Ingenia 1.5T, Ingenia 3.0T, Ingenia 1.5T CX, Ingenia 3.0T CX, Ingenia Elition S, Ingenia Elition X, Ingenia Ambition S, Ingenia Ambition X and MR 5300 MR Systems are substantially equivalent to the legally marketed predicate devices in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.

Additionally, substantial equivalence is demonstrated with non-clinical performance (verification and validation) tests, which complied with the requirements specified in the international and FDA-recognized consensus standards and device-specific guidance.

The results of these tests demonstrate that the subject Achieva, Intera, Ingenia 1.5T, Ingenia 3.0T, Ingenia 1.5T CX, Ingenia 3.0T CX, Ingenia Elition S, Ingenia Elition X, Ingenia Ambition S, Ingenia Ambition X and MR 5300 MR Systems meet the acceptance criteria and are adequate for the intended use.

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.