(187 days)
No
The document describes "Compressed sensing in combination with SENSE" for image reconstruction, which is a signal processing technique, not explicitly AI/ML. There is no mention of AI, ML, or related terms like deep learning or neural networks.
No
The intended use states it is a "diagnostic device" and that images "may assist the diagnosis and therapy planning," but it does not perform therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This system is a Magnetic Resonance Medicated for use as a diagnostic device." It further clarifies that images, spectra, and measurements, when interpreted by a trained physician, "provide information that may assist the diagnosis and therapy planning."
No
The device description explicitly refers to "magnet systems" (60 cm and 70 cm) and "MRI systems," indicating the presence of hardware components beyond just software. While software is a key part of the system, it is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this system is a Magnetic Resonance device that produces images and spectra of the internal structure of the head, body, or extremities. It works by detecting the spatial distribution of protons or other nuclei within the body.
- No Specimen Analysis: There is no mention of analyzing specimens taken from the body. The device interacts directly with the patient's body to generate images.
Therefore, this device falls under the category of an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This system is a Magnetic Resonance Medicated for use as a diagnostic device. The system can produce cross-sectional images 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 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.
Product codes
LNH, LNI
Device Description
The proposed Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 with Compressed SENSE feature is applicable for the 60 cm (CX) and 70 cm magnet systems. The systems and control software are substantially equivalent to the legally marketed primary predicate device Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3T R5.3 (K163116, 01/06/2017).
The proposed Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 with the Compressed SENSE feature also includes minor software changes since the clearance of the legally marketed primary predicate device, Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3T R5.3 (K163116, 01/06/2017).
The following modifications are covered in this submission:
- Upgrade software platform to Windows 10
- Compressed SENSE feature allows ultra-high acceleration factors for shorter scan times and higher resolution in 2D and 3D imaging based on the principle of Compressed sensing in combination with SENSE.
- PerformanceBridge Protocol Manager Release 1.0 offering intended to help customers increase collaboration within a healthcare facility group. Customers will enter the Protocol Manager cloud functionality via the PerformanceBridge portal. Protocol Manager is a subscription service to a cloud based protocol repository that will allow a user to standardize protocols over the various connected MRI systems, enable editing of protocols and scan parameters and make central protocols available for use on local MRI systems.
The proposed Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T, Ingenia 1.5T CX, and Ingenia 3.0T CX R5.4 with Compressed SENSE feature is intended to be marketed with the following pulse sequences and coils that were previously cleared by FDA:
- mDIXON K102344
- SWIp K131241
- mDIXON-Quant K133526
- MRE K140666
- mDIXON XD K143128
- O-MAR K143253
- MultiBand SENSE K143606
- Ingenia Coils See Appendix 004 and Appendix 007
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
head, body, extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician, clinical user, hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical verification and or 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, combined with sample clinical images demonstrate that the proposed Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 with the Compressed SENSE feature:
• Complies with the aforementioned international and FDA recognized consensus standards and Device specific guidance document, entitled "Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices – November 18, 2016"
• Meets the acceptance criteria and is adequate for its intended use.
The proposed Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 with the Compressed SENSE feature did not require a clinical study since substantial equivalence to the legally marketed predicate device was proven with the verification/validation testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K102344, K131241, K133526, K140666, K143128, K143253, K143606
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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April 4, 2018
Philips Medical Systems Nederland B.V. % Susan Ouick Regulatory Affairs Philips Medical Systems (Cleveland) Inc 595 Miner Road Cleveland, Ohio 44143
Re: K173079
Trade/Device Name: Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI Dated: March 20, 2018 Received: March 22, 2018
Dear Susan 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. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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 A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K173079
Device Name
Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4
Indications for Use (Describe)
This system is a Magnetic Resonance Medicated for use as a diagnostic device. The system can produce cross-sectional images 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 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.
| 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:
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"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."
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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: | September 27, 2017 |
|---|---|
| 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 | |
| Phone: (440) 483-2291 | |
| E-mail: susan.quick@philips.com | |
| Device Name: | Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and |
| Ingenia 3.0T CX R5.4 | |
| 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 3T R5.3 |
| Manufacturer: Philips Medical Systems Nederland B.V. | |
| 510(k) Clearance: K163116 | |
| Classification Regulation: 21CFR 892.1000 | |
| Classification name: Magnetic Resonance Diagnostic Device (MRDD) | |
| Classification Panel: Radiology | |
| Device class Class II | |
| Product Code: 90LNH | |
| 90LNI |
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| Device Description: | The proposed Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia
3.0T, and Ingenia 3.0T CX R5.4 with Compressed SENSE feature is
applicable for the 60 cm (CX) and 70 cm magnet systems. The systems
and control software are substantially equivalent to the legally marketed
primary predicate device Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3T
R5.3 (K163116, 01/06/2017). |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The proposed Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia
3.0T, and Ingenia 3.0T CX R5.4 with the Compressed SENSE feature
also includes minor software changes since the clearance of the legally
marketed primary predicate device, Ingenia 1.5T, Ingenia 1.5T S and
Ingenia 3T R5.3 (K163116, 01/06/2017). |
| | The following modifications are covered in this submission: |
| | 1. Upgrade software platform to Windows 10 |
| | 2.
Compressed SENSE feature allows ultra-high acceleration
factors for shorter scan times and higher resolution in 2D and 3D
imaging based on the principle of Compressed sensing in
combination with SENSE. |
| | 3.
PerformanceBridge Protocol Manager Release 1.0 offering
intended to help customers increase collaboration within a
healthcare facility group. Customers will enter the Protocol
Manager cloud functionality via the PerformanceBridge portal. |
| | Protocol Manager is a subscription service to a cloud based
protocol repository that will allow a user to standardize protocols
over the various connected MRI systems, enable editing of
protocols and scan parameters and make central protocols
available for use on local MRI systems. |
| | The proposed Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T, Ingenia
1.5T CX, and Ingenia 3.0T CX R5.4 with Compressed SENSE feature
is 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
8. Ingenia Coils See Appendix 004 and Appendix 007 |
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| Indications for Use: | This system is a Magnetic Resonance Medical Electrical Systems
indicated 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 anatomy, 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 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. |
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| Design Features/
Fundamental Scientific
Technology: | The proposed Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia
3.0T, and Ingenia 3.0T CX R5.4 with the Compressed SENSE feature
are 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. |
|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The principal technological components (magnet, transmit body
coil, gradient coil, receive coils and patient support) of the proposed
Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and
Ingenia 3.0T CX R5.4 with the Compressed SENSE feature are
identical to those used in the legally marketed primary predicate device
Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3T R5.3 (K163116,
01/06/2017). |
| | Compressed SENSE enables scan time reduction or improved spatial
resolution through non-equidistant k-space sampling and regularized
reconstruction methods with automatic parameter tuning. The
Compressed SENSE feature allows ultra-high acceleration factors for
shorter scan times and higher resolution in 2D and 3D imaging based on
the principle of Compressed sensing in combination with SENSE. The
use of Compressed SENSE is limited to non-contrast enhanced exams. |
| | Based on the information provided above, the proposed Ingenia 1.5T,
Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX
R5.4 with the Compressed SENSE feature does not raise different
questions of safety and effectiveness compare to the legally marketed
primary predicate device Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3T
R5.3 (K163116, 01/06/2017). |
| Summary of Non-Clinical
Performance Data: | The proposed Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia
3.0T, and Ingenia 3.0T CX R5.4 with the Compressed SENSE feature
comply with the following international and FDA-recognized consensus
standards:
• IEC60601-1-2 Edition 3
• IEC60601-1-6 Edition 3
• IEC62366 (2015)
• IEC60601-1-8 Edition 2
• IEC60601-2-33 Edition 3
• IEC 62304 (2006)
• ISO 14971 Application of risk management to medical devices (2007)
• Device specific guidance document, entitled "Guidance for the
Submission Of Premarket Notifications for Magnetic Resonance
Diagnostic Devices – November 18, 2016"
• Guidance for Industry and FDA Staff - Guidance for the Content of
Premarket Submissions for Software Contained in Medical Devices
(issued May 11, 2005)
• Guidance for Industry and FDA Staff - Applying Human Factors and
Usability Engineering to Medical Devices 9 issued February 3, 2016)
• Guidance for Industry and FDA Staff – Content of Premarket
Submissions for Management of Cybersecurity in Medical Devices
issued October 2, 2014 |
| | Non-Clinical verification and or 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, combined with sample
clinical images demonstrate that the proposed Ingenia 1.5T, Ingenia
1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 with
the Compressed SENSE feature:
• Complies with the aforementioned international and FDA
recognized consensus standards and Device specific guidance
document, entitled "Guidance for the Submission Of Premarket
Notifications for Magnetic Resonance Diagnostic Devices –
November 18, 2016"
• Meets the acceptance criteria and is adequate for its intended
use. |
| | Therefore, the proposed Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T
CX, Ingenia 3.0T, and Ingenia 3.0T CX R5.4 with the Compressed
SENSE feature are substantially equivalent to the legally marketed
primary predicate device Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3T |
| Summary of Clinical Data: | The proposed Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia
3.0T, and Ingenia 3.0T CX R5.4 with the Compressed SENSE feature
did not require a clinical study since substantial equivalence to the
legally marketed predicate device was proven with the
verification/validation testing. |
| Substantial Equivalence: | The proposed Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia
3.0T, and Ingenia 3.0T CX R5.4 with the Compressed SENSE feature
and the legally marketed primary predicate device Ingenia 1.5T, Ingenia
1.5T S and Ingenia 3T R5.3 (K163116, 01/06/2017) have the same
indications for use with respect to the following:
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 proposed Ingenia 1.5T, Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia
3.0T, and Ingenia 3.0T CX R5.4 with the Compressed SENSE feature
are substantially equivalent to the legally marketed primary predicate
device Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3T R5.3 (K163116,
01/06/2017) in terms of design features, fundamental scientific
technology, indications for use, and safety and effectiveness.
Additionally, substantial equivalence was 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. |
| Conclusion: | The results of these tests demonstrate that the proposed Ingenia 1.5T,
Ingenia 1.5T S, Ingenia 1.5T CX, Ingenia 3.0T, and Ingenia 3.0T CX
R5.4 with the Compressed SENSE feature meet the acceptance criteria
and is adequate for its intended use. |
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