← Product Code [LNH](/productcode/LNH) · K181479 # Ingenia Ambition S and Ingenia Ambition X (K181479) _Philips Medical Systems Nederland B.V. · LNH · Aug 3, 2018 · Radiology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K181479 ## Device Facts - **Applicant:** Philips Medical Systems Nederland B.V. - **Product Code:** [LNH](/productcode/LNH.md) - **Decision Date:** Aug 3, 2018 - **Decision:** SESE - **Submission Type:** Abbreviated - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Indications for Use This system is a Magnetic Resonance Medicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities. Magnetic Resonance images represent the spatial distribution of protons or other nuclei with spin. Image appearance is determined by many different physical properties of the tissue and the MR scan technique applied. The image acquisition process can be synchronized 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 the 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. The use of contrast agents for diagnostic imaging applications should be performed consistent with the approved labeling for the contrast agent. 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 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 Story Magnetic resonance diagnostic device; utilizes strong magnetic field and radiofrequency pulses to excite atomic nuclei; detects relaxation signals; reconstructs images/spectra. Features sealed magnet with internal cooling system (helium-filled, closed-loop, no quench vent required); modified RF amplifier. Workflow enhancements: VitalScreen (touchscreen patient setup guidance); Autostart (automated sequence initiation upon door closure); VitalEye (camera-based breathing detection for synchronization); ContrastCards (DICOM metadata for contrast agents); SyntAc (MDME image acquisition for synthetic MRI processing). Used in clinical settings by trained physicians/technicians. Output: cross-sectional images, spectra, and physical parameter maps. Benefits: diagnostic information for therapy planning; workflow efficiency; reduced helium dependency. ## Clinical Evidence No clinical study performed. Substantial equivalence established via bench-only verification and validation testing, including compliance with consensus standards (IEC, NEMA, ISO). Representative clinical images provided in DICOM format to demonstrate image quality. ## Technological Characteristics Magnetic resonance diagnostic device; 1.5T/3.0T field strength; sealed superconducting magnet with closed-loop helium cooling; modified RF amplifier. Connectivity: DICOM/HL7/FHIR/IHE. Software: R5.5 control system. Standards: IEC 60601-1, IEC 60601-2-33, NEMA MS-1/4/8, ISO 14971. ## Regulatory 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). ## Special Controls *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. ## Predicate Devices - Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 ([K173079](/device/K173079.md)) ## Reference Devices - Ingenia Elition S and Ingenia Elition X ([K173451](/device/K173451.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ August 3, 2018 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Philips Medical Systems Nederland B.V. % Ms. Susan Quick Regulatory Affairs Specialist Philips Medical Systems (Cleveland), Inc. 595 Miner Road CLEVELAND OH 44143 Re: K181479 Trade/Device Name: Ingenia Ambition S and Ingenia Ambition X Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, LNI Dated: May 31, 2018 Received: June 5, 2018 Dear Ms. Quick: 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 (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 located 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. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good {1}------------------------------------------------ manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Michael D. O'Hara For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) ### K181479 Device Name Ingenia Ambition S and Ingenia Ambition X #### Indications for Use (Describe) This system is a Magnetic Resonance Medicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities. Magnetic Resonance images represent the spatial distribution of protons or other nuclei with spin. Image appearance is determined by many different physical properties of the tissue and the MR scan technique applied. The image acquisition process can be synchronized 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 the 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. The use of contrast agents for diagnostic imaging applications should be performed consistent with the approved labeling for the contrast agent. 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 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. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------| | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [PRAStaff@fda.hhs.gov](mailto:PRAStaff@fda.hhs.gov) *"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."* {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and aligned horizontally. The background is plain white, which makes the blue letters stand out. # Ingenia Ambition S and Ingenia Ambition X Section 5 510(k) Summary {4}------------------------------------------------ ## 510(k) Summary of Safety and Effectiveness This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92. | Date Prepared: | June 01, 2018 | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer: | Philips Medical Systems Nederland B.V.
Veenpluis 4-6, 5684 PC, Best, The Netherlands
Establishment Registration Number: 3003768277 | | Primary Contact Person: | Jan van de Kerkhof
Sr. Manager Regulatory Affairs
Phone: +31 613300542
E-mail: jan.van.de.kerkhof@philips.com | | Secondary Contact Person | Susan Quick
Regulatory Affairs Specialist
Telephone: (440) 869-4612
E-mail: susan.quick@philips.com | | Device Name: | Ingenia Ambition S and Ingenia Ambition X | | Classification: | Classification name: Magnetic Resonance Diagnostic Device (MRDD)
Classification Regulation: 21CFR 892.1000
Classification Panel: Radiology
Device Class: Class II
Primary Product Code: 90LNH
90LNI | | Primary Predicate Device: | Trade name: Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4
Manufacturer: Philips Medical Systems Nederland B.V.
510(k) Clearance: K173079
Classification Regulation: 21CFR 892.1000
Classification name: Magnetic Resonance Diagnostic Device (MRDD)
Classification Panel: Radiology
Device class: Class II
Product Code: 90LNH
90LNI | | Reference Device: | Trade name: Ingenia Elition S and Ingenia Elition X
Manufacturer: Philips Medical Systems Nederland B.V.
510(k) Clearance: K173451
Classification Regulation: 21CFR 892.1000
Classification name: Magnetic Resonance Diagnostic Device (MRDD) | | Device class | Class II | | Product Code: | 90LNH
90LNI | | Device Description: | The proposed Ingenia Ambition S and Ingenia Ambition X R5.5 with
sealed magnet, modified RF amplifier and Workflow Solution are
modifications of the 70 cm Ingenia 1.5T system, included in the legally
marketed predicate device Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T
CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 (K173079, 04/04/2018).
The systems and control software provided with the proposed Ingenia
Ambition S and Ingenia Ambition X are substantially equivalent to the
legally marketed predicate device Ingenia 1.5T, Ingenia 1.5T S, Ingenia
1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 (K173079,
04/04/2018).

Hereafter in this submission, Ingenia Ambition S and Ingenia
Ambition X will be used to indicate the proposed device Ingenia
Ambition S and Ingenia Ambition X R5.5 with sealed magnet,
modified RF amplifier and Workflow Solution.

The proposed Ingenia Ambition S and Ingenia Ambition X also
includes minor software changes since the clearance of the legally
marketed predicate device, Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T
CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 (K173079, 04/04/2018).

The following modifications to the proposed Ingenia Ambition S and
Ingenia Ambition X are included in this submission:

1. Introduction of sealed magnet and modified RF amplifier;
2. Introduction of new product name and covers;
3. VitalScreen: Touch Screen for guidance for patient setup: Touch
screen at magnet fa çade to give user guidance on how to prepare
a patient;
4. Autostart: automatic start of scanning at RF Door Closure:
Possibility for an operator to start a sequence by pressing the Start
button at the controls at the magnet fa çade, the scan will then start
the necessary preparations to be able to start the sequence
(transmitting and receiving of RF-signals and generating gradient
waveforms) when the RF door is closed.
5. VitalEye: automatic breathing detection using camera: A camera
solution for detecting breathing patterns of the patient. The MR
scanner translates real-time camera images of the patient, to real-
time breathing wave forms. The acquisition system of the MR
scanner will use these breathing wave forms to synchronize the
internals of the sequence: | | 6. ContrastCards: offers the ability to add information on the contrast
agent. After applying the contrast agent, which is done independent
from the MR system, information on the applied contrast is added
to the DICOM images. When viewing these images on the MR
system the images which have been taken while contrast was
applied are marked with an indication "Contrast".
The feature helps the operator to indicate which sequence needs
contrast and after applying contrast it helps indicate which images
are taken while contrast was injected. Still, the use of contrast
agents for diagnostic imaging applications shall be performed
consistent with the approved labeling for the contrast agent. | | | 7. SyntAc (MDME): acquisition of Multi-Dynamic Multi-Echo (MDME)
images. These images can be processed by 3rd party (Synthetic
MRI) software to produce the relevant radiological contrasts. | | | Note: The VitalScreen (3), AutoStart (4), VitalEye (5), ContrastCards (6)
and SyntAc (MDME) (7) features have been already cleared for the
legally marketed reference device Ingenia Elition S and Ingenia Elition
X systems (K173451) and are integrated in the proposed Ingenia
Ambition S and Ingenia Ambition X without any further modifications
compared to K173451. | | | The proposed Ingenia Ambition S and Ingenia Ambition X are
intended to be marketed with the following pulse sequences and coils
that were previously cleared by FDA: | | | 1. mDIXON K102344 | | | 2. SWIp K131241 | | | 3. mDIXON-Quant K133526 | | | 4. MRE K140666 | | | 5. mDIXON XD K143128 | | | 6. O-MAR K143253 | | | 7. MultiBand SENSE K143606 |… --- **Source:** [https://fda-staging.innolitics.com/device/K181479](https://fda-staging.innolitics.com/device/K181479) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com