(214 days)
No
The document does not mention AI, ML, or related terms, and the description focuses on hardware and software updates for a standard MR system.
No
The "Intended Use / Indications for Use" states that the system is "indicated for use as a diagnostic device" and provides information that "may assist the diagnosis and therapy planning," but its primary function is diagnostic imaging, not therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system "is a Magnetic Resonance Medical Electrical System indicated for use as a diagnostic device." Additionally, the "Device Description" also refers to it as "magnetic resonance diagnostic devices."
No
The device description explicitly states it includes hardware components such as a magnet, RF receive coils, patient support, gradient system, and RF transmit system, in addition to control software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this system is a Magnetic Resonance Medical Electrical System that produces images and spectra of the internal structure of the head, body, or extremities. It uses magnetic fields and radio waves to create these images.
- Lack of Sample Analysis: There is no mention of analyzing biological samples taken from the patient. The device directly interacts with the patient's body to acquire data.
Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
This system is a Magnetic Resonance Medical Electrical System 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 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, MOS
Device Description
The proposed Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 are 60 cm bore 1.5 Tesla (1.5T) magnetic resonance diagnostic devices. The systems and control software are substantially equivalent to the currently marketed predicate device Ingenia 1.5T CX R5.3 (K162931, 01/06/2017).
The system includes a new 1.5T magnet, new set of RF receive coils, new patient support, new in-house Gradient system and RF transmit system and adapted RF receive system which is substantially equivalent to the currently marketed predicate device Ingenia 1.5T CX R5.3.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
head, body or 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)
The proposed Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 did not require clinical study since substantial equivalence to the legally marketed predicate device was proven with the verification/validation testing.
Clinical sample images were provided to support the ability of proposed Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 to generate diagnostic quality images.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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June 15, 2018
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 Healthcare (Suzhou) Co., Ltd. % Jacky Shi Senior Regulatory Engineer No. 258, Zhongyuan Road Suzhou Industrial Park Suzhou, Jiangsu 215024 CHINA
Re: K173507
Trade/Device Name: Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, LNI, and MOS Dated: May 30, 2018 Received: June 6, 2018
Dear Jacky Shi:
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 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);
1
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K173507
Device Name
Prodiva 1.5T CX and Prodiva 1.5T CS R5.4
Indications for Use (Describe)
This system is a Magnetic Resonance Medical Electrical System 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 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)
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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: | November 8, 2017 | |||
|---|---|---|---|---|
| Manufacturer: | Philips Healthcare (Suzhou) Co., Ltd. | |||
| No. 258, Zhongyuan Road, Suzhou Industrial Park, Suzhou Jiangsu, CHINA, 215024 | ||||
| Establishment Registration Number: 3009529630 | ||||
| Primary Contact | ||||
| Person: | Jacky Shi | |||
| Senior Regulatory Engineer | ||||
| Phone: +86 512-67336881 | ||||
| E-mail: Jacky.Shi@philips.com | ||||
| Secondary Contact | ||||
| Person | Gordon Shu | |||
| Senior Regulatory Manager | ||||
| Phone: +86-512-67336804 | ||||
| E-mail: Gordon.Shu@philips.com | ||||
| Device Name: | ||||
| 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 | ||||
| 90MOS | ||||
| Primary Predicate | ||||
| Device: System | Trade name: | Ingenia 1.5T CX R5.3 | ||
| Manufacturer: | Philips Medical Systems | |||
| Nederland B.V. | ||||
| 510(k) Clearance: | K162931 | |||
| Classification Regulation: | 21CFR 892.1000 | |||
| Classification name: | Magnetic resonance diagnostic device (MRDD) | |||
| Classification Panel: | Radiology | |||
| Device class | Class II | |||
| Product Code: | 90LNH | |||
| 90LNI | ||||
| Reference Predicate | ||||
| Device: Coils | Trade name: | dS Anterior, dS Base, dS | ||
| Head-neck, dS Head, Flex | ||||
| (S, M L) | ||||
| Manufacturer: | PHILIPS MEDICAL | |||
| SYSTEMS | ||||
| 3545 s w 47th avenue | ||||
| Gainesville, FL 32608 -1099 | ||||
| 510(k) Clearance: | K123492 | |||
| Classification Regulation: | 21CFR 892.1000 | |||
| Classification name: | Coil, Magnetic Resonance, | |||
| Specialty |
Premarket Notification [510(k)] Submission Philips Healthcare (Suzhou) Co., Ltd. Prodiva 1.5T CX and Prodiva 1.5T CS R5.4
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Philips Healthcare (Suzhou) Co., Ltd. Abbreviated 510(k)
| Device class | Class II |
|---|---|
| Product Code: | 90MOS |
| Device Description: | The proposed Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 are 60 cm bore 1.5 Tesla (1.5T) magnetic resonance diagnostic devices. The systems and control software are substantially equivalent to the currently marketed predicate device Ingenia 1.5T CX R5.3 (K162931, 01/06/2017). |
The system includes a new 1.5T magnet, new set of RF receive coils, new patient support, new in-house Gradient system and RF transmit system and adapted RF receive system which is substantially equivalent to the currently marketed predicate device Ingenia 1.5T CX R5.3. |
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Philips Healthcare (Suzhou) Co., Ltd. Abbreviated 510(k)
| Indications for Use: | This system is a Magnetic Resonance Medical Electrical
System 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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Philips Healthcare (Suzhou) Co., Ltd. Abbreviated 510(k)
| Fundamental | The proposed Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 |
|---|---|
| Scientific | are based on the principle that certain atomic nuclei present |
| Technology: | 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 Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 | |
| substantially equivalent to the currently marketed predicate | |
| device Ingenia 1.5T CX R5.3 (K162931, 01/06/2017). | |
| Based on the information provided above, the proposed | |
| Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 does not raise | |
| different questions of safety and effectiveness compare to | |
| the currently marketed predicate device Ingenia 1.5T CX | |
| R5.3 (K162931, 01/06/2017). |
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| Summary of Non-Clinical Performance Data: | The proposed Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 comply with the following international and FDA-recognized consensus standards: |
|---|---|
| IEC 60601-2-33 Edition 3.1: 2013 | |
| Medical Electrical Equipment - Part 2-33: Particular | |
| Requirements For The Basic | |
| Safety And Essential Performance Of Magnetic | |
| Resonance Equipment For Medical Diagnosis. | |
| FDA/CDRH recognition number 12-271 AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, | |
| C1:2009/(R) 2012 and A2:2010/(R) 2012 (Consolidated | |
| Text) Medical Electrical Equipment - Part 1: General | |
| Requirements For Basic Safety And Essential | |
| Performance (IEC 60601-1:2005, MOD). | |
| FDA/CDRH recognition number 19-4 IEC 60601-1-2 Edition 3: 2007-03 | |
| Medical Electrical Equipment - Part 1-2: General | |
| Requirements For Basic Safety And Essential | |
| Performance - Collateral Standard: Electromagnetic | |
| Compatibility -Requirements And Tests | |
| FDA/CDRH recognition number 19-1 IEC 60601-1-6 Edition 3.1: 2013-10 | |
| Medical Electrical Equipment -- Part 1-6: General | |
| Requirements For Basic Safety And Essential | |
| Performance -- Collateral Standard: Usability | |
| FDA/CDRH recognition number 5-89 IEC 62366 Edition 1.1: 2014-01 | |
| Medical devices - Application of usability engineering to | |
| medical devices | |
| FDA/CDRH recognition number 5-87 IEC 62304 Edition 1.1: 2015 | |
| Medical device software - Software life cycle processes. | |
| FDA recognition number 13-79 ISO14971 Edition 2: 2007-03-01 | |
| Medical devices - Application of risk management to | |
| medical devices. | |
| FDA/CDRH recognition number 5-40 NEMA MS 1-2008 | |
| Determination of Signal-To-Noise Ratio (SNR) in | |
| Diagnostic Magnetic Resonance Imaging | |
| FDA/CDRH recognition number 12-188 NEMA MS 2-2008 (R2014) | |
| Determination of Two-Dimensional Geometric Distortion in | |
| Diagnostic Magnetic Resonance Images | |
| FDA/CDRH recognition number 12-196 | |
| ● | NEMA MS 3-2008 (R2014) |
| Determination of Image Uniformity in Diagnostic Magnetic | |
| Resonance Images | |
| FDA/CDRH recognition number 12-187 | |
| ● | NEMA MS 4-2010 |
| Acoustic Noise Measurement Procedure for Diagnosing | |
| Magnetic Resonance Imaging Devices. | |
| FDA/CDRH recognition number 12-232 | |
| ● | NEMA MS 5-2009 |
| Determination of Slice Thickness in Diagnostic Magnetic | |
| Resonance Imaging | |
| FDA/CDRH recognition number 12-231 | |
| ● | NEMA MS 6-2008 (R2014) |
| Determination of Signal-to-Noise Ratio and Image | |
| Uniformity for Single-Channel, Non-Volume Coils in | |
| Diagnostic Magnetic Resonance Imaging (MRI) | |
| FDA/CDRH recognition number 12-195 | |
| ● | NEMA MS 8-2008 |
| Characterization of the Specific Absorption Rate for | |
| Magnetic Resonance Imaging Systems | |
| FDA/CDRH recognition number 12-192 | |
| ● | NEMA MS 9-2008 (R2014) |
| Characterization of Phased Array Coils for Diagnostic | |
| Magnetic Resonance Images (MRI) | |
| FDA/CDRH recognition number 12-288 | |
| ● | NEMA MS 12-2016 |
| Quantification and Mapping of Geometric Distortion for | |
| Special Applications | |
| FDA/CDRH recognition number 12-306 | |
| ● | NEMA PS 3.1-PS 3.20 - [DICOM] Digital Imaging and |
| Communications in Medicine, Parts 1 - 20 | |
| FDA recognition number 12-300 | |
| ● | Device specific guidance document, entitled Guidance for |
| the Submission of Premarket Notifications for Magnetic | |
| Resonance Diagnostic Devices (issued November 18, |
-
|
| ● | 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 - Content of
Premarket Submissions for Management of Cybersecurity
in Medical Devices (issued October 2, 2014) |
| | Guidance for Industry and FDA Staff— Applying Human
Factors and Usability Engineering to Optimize Medical
Device Design (issued Feb. 03, 2016) Guidance for Industry and FDA Staff - Use of
International Standard ISO 10993-1, "Biological
evaluation of medical devices - Part 1: Evaluation and
testing within a risk management process" (issued June
16, 2016) Guidance for Industry and FDA Staff - Information to
Support a Claim of Electromagnetic Compatibility (EMC)
of Electrically-Powered Medical Devices (issued July 11,
2016) |
| | 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 validation test results, combined with
sample clinical images demonstrate that the proposed
Prodiva 1.5T CX and Prodiva 1.5T CS R5.4: |
| | 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 Prodiva 1.5T CX and Prodiva
1.5T CS R5.4 are substantially equivalent to the currently
marketed predicate device Ingenia 1.5T CX R5.3 (K162931,
01/06/2017) in terms of safety and effectiveness. |
| Summary of Clinical | The proposed Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 |
| Data: | did not require clinical study since substantial equivalence
to the legally marketed predicate device was proven with |
| | the verification/validation testing. |
| | Clinical sample images were provided to support the ability
of proposed Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 to
generate diagnostic quality images. |
| Substantial
Equivalence
Conclusion: | The proposed Prodiva 1.5T CX and Prodiva 1.5T CS R5.4
and the currently marketed predicate device Ingenia 1.5T
CX R5.3 (K162931, 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 Prodiva 1.5T CX and Prodiva 1.5T CS R5.4
are substantially equivalent to the currently marketed
predicate device Ingenia 1.5T CX R5.3 (K162931,
01/06/2017) in terms of design features, fundamental
scientific technology, indications for use, and safety &
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. |
| | The results of these tests demonstrate that the proposed
Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 meet the
acceptance criteria and is adequate for its intended use. |
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