Who is the manufacturer of MR 5300?

Philips Medical Systems Nederland B.V. filed the 510(k) submission for MR 5300 (K212673).

What is the FDA product code for MR 5300?

LNH. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for MR 5300?

510(k) clearance (submission type: Abbreviated).

Who can help prepare an FDA 510(k) submission like MR 5300?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MR 5300

K212673 · Philips Medical Systems Nederland B.V. · LNH · Nov 19, 2021 · Radiology

Device Facts

Record ID	K212673
Device Name	MR 5300
Applicant	Philips Medical Systems Nederland B.V.
Product Code	LNH · Radiology
Decision Date	Nov 19, 2021
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 892.1000
Device Class	Class 2

Intended Use

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

MR 5300 is a 1.5 Tesla MRI system; utilizes magnetic resonance phenomenon to generate cross-sectional images, spectroscopic images, and spectra of internal structures. Input: atomic nuclei relaxation signals in strong magnetic field; Output: computed image reconstruction on video screen. Operated by trained physicians/clinicians in clinical settings. Features 'Breeze Workflow Solution' including 16-channel dS interface for coil connectivity and improved patient table/mattress ergonomics. Clinicians adjust scan parameters to customize image appearance, accelerate acquisition, and synchronize with physiological cycles. Output assists in diagnosis, therapy planning, and guidance of interventional procedures. Benefits include high-quality diagnostic imaging and support for minimally invasive interventions.

Clinical Evidence

No clinical data. Substantial equivalence was demonstrated through non-clinical verification and validation testing, including compliance with international consensus standards (IEC 60601 series, NEMA MS series, ISO 14971).

Technological Characteristics

1.5 Tesla MRI system with 70 cm bore. Components: magnet, transmit body coil, gradient coil, gradient amplifier, RF amplifier, patient support. Connectivity: 16-channel dS interface for coil connection. Software: R5.8. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, NEMA MS-1/4/8, ISO 14971.

Indications for Use

Indicated for use as a diagnostic device by trained physicians to obtain cross-sectional images, spectroscopic images, and spectra of the head, body, or extremities in any orientation. Supports MR fluoroscopy for interventional and minimally invasive procedures. No specific patient population age or gender restrictions provided.

Regulatory Classification

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

Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems (K193215)

Reference Devices

mDIXON (K102344)
SWlp (K131241)
mDIXON-Quant (K133526)
mDIXON XD (K143128)
O-MAR (K143253)
MultiBand SENSE software application (K162940)

Related Devices

K190461 — Achieva 1.5T, 3.0T and Intera 1.5T MR Systems · Philips Medical Systems Nederland B.V. · Jun 4, 2019
K052978 — GE 1.5T SIGNA HDE MR SYSTEM · Ge Medical Systems, LLC · Nov 9, 2005
K121160 — MAGNETOM SPECTRA · Siemens Medical Solutions USA, Inc. · Jul 16, 2012
K173507 — Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 · Philips Healthcare (Suzhou) Co., Ltd. · Jun 15, 2018
K182129 — MAGNETOM Sola · Siemens Medical Solutions USA, Inc. · Oct 12, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Philips Medical Systems Nederland B.V. % Jan van de Kerkhof Sr. Manager Regulatory Affairs Veenpluis 4-6 5684 PC Best THE NETHERLANDS Re: K212673 Trade/Device Name: MR 5300 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI Dated: August 23, 2021 Received: August 24, 2021 Dear Jan van de Kerkhof: 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 {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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. Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) #### K212673 Device Name MR 5300 #### Indications for Use (Describe) Philips Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. 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 extremites, 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. 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. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, which makes the blue letters stand out. The word is centered in the image. Philips Medical Systems Nederland B.V. Magnetic Resonance Imaging Abbreviated 510(k) # MR 5300 # 510(k) Summary {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The color of the text is blue. The background is white, providing a strong contrast that makes the brand name stand out. ### 510(k) Summary of Safety and Effectiveness This 510(k) summary is prepared in accordance with 21 CFR §807.92. | Date Prepared: | Aug 23, 2021 | |------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer: | Philips Medical Systems Nederland B.V. Veenpluis 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 | AN Ce Regulatory Affairs Specialist Telephone: +31 638161043 E-mail: ce.an@philips.com | | Device Name: | MR 5300 | | 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: Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, And Ingenia Ambition MR Systems Manufacturer: Philips Medical Systems Nederland B.V. 510(k) Clearance: K193215 Classification Regulation: 21CFR 892.1000 Classification name: Magnetic Resonance Diagnostic Device (MRDD) Classification Panel: Radiology Device class Class II Product Code: 90LNH 90L NI | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The proposed MR 5300 R5.8 with Breeze Workflow Solution is a 70 Device Description: cm bore 1.5 Tesla (1.5T) Magnetic Resonance Diagnostic Device, hereafter to be known as MR 5300. Philips Medical Systems Nederland B.V. believes that the proposed MR 5300 is a modification of our legally marketed devices Achieva, Intera, Ingenia, Inqenia CX, Ingenia Elition and Ingenia Ambition MR systems (K193215, 04/10/2020), among which MR 5300 is specifically predicated to the Ingenia Ambition S. In this 510(k) submission, Philips Medical Systems Nederland B.V. will be addressing the following modifications to the proposed MR 5300 when compared to the legally marketed predicate Ingenia Ambition S: 1. Introduction of new product model: MR 5300 2. Introduction of Breeze Workflow Solution: a. dS Interface: newly developed 16 channel dS interface to connect coils to the MR 5300 system. The dS Interface allows to connect two coils at the same time to one dS Interface. dS Interface is available in two variants: dS interface S 1.5T with a short cable o dS interface L 1.5T with a longer cable O b. Rearrangement of connector layout of the patient table to fit to the dS Interface. Connectors are not changed. Comfort Mattress Partner to improve patient setup, C. patient comfort and cable management. Besides enable the new product model MR 5300 and the coils mentioned above. There is no new software features introduced in SW R5.8. The proposed MR 5300 is intended to be marketed with the following pulse sequences and coils that are previously cleared by FDA: 1. mDIXON (K102344) 2. SWlp (K131241) 3. mDIXON-Quant (K133526) 4. mDIXON XD (K143128) 5. O-MAR (K143253) 6. MultiBand SENSE software application (K162940), to support MutiBand SENSE for 1.5T and to support diffusion body imaging on 1.5T and 3.0T. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill most of the frame. The background is white, providing a strong contrast to the blue text. | Indications for Use: | The indications for use, provided below, of the proposed MR 5300 is the same as the legally marketed predicate device Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR systems (K193215, 04/10/2020), among which MR 5300 is specifically predicated to the Ingenia Ambition S. Philips Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. 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 | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. | Design Features/ Fundamental Scientific Technology: | The proposed MR 5300 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. The principal technological components (magnet, transmit body coil, gradient coil, gradient amplifier, RF amplifier and patient support) of the proposed MR 5300 is identical to those used in the legally marketed predicate device Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR systems (K193215, 04/10/2020), among which MR 5300 is specifically predicated to Ingenia Ambition S. | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Summary of Non- Clinical Performance Data: | The proposed MR 5300 complies with the following international and FDA-recognized consensus standards: IEC60601-1 Edition 3 IEC60601-1-2 Edition 4 IEC60601-1-6 Edition 3 IEC62366-1 Edition 1 IEC60601-1-8 Edition 2 IEC60601-2-33 Edition 3 IEC 62304 Edition 1 NEMA MS-1 2008 NEMA MS-4 2010 NEMA MS-8 2008 NEMA PS 3.1-PS 3.20 ISO 14971 Edition 2 Device specific guidance document, entitled "Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices" (issued November 18, 2016 – document number 340) Guidance for Industry and FDA Staff – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 11, 2005 - document number 337) Guidance for Industry and FDA Staff – Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (issued October 2, 2014 – document number 1825) Guidance for Industry and FDA Staff – Applying Human Factors and Usability Engineering to Medical Devices (issued February 3, 2016 - document number 1757) 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 – document number 1811) Guidance for Industry and FDA Staff – Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically- | | | Powered Medical Devices (issued July 11, 2016 – document number 1400057) Guidance for Industry and FDA Staff – Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices (issued September 6, 2017 – document number 1500015) 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 demonstrate that the proposed MR 5300: | | | Comply 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" Meet the acceptance criteria and is adequate for its intended use. | | | Therefore, the proposed MR 5300 is substantially equivalent to the legally marketed predicate device Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR systems (K193215, 04/10/2020), among which MR 5300 is specifically predicated to Ingenia Ambition S in terms of safety and effectiveness. | | Summary of Clinical Data: | The proposed MR 5300 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 MR 5300 and the legally marketed predicate device Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR systems (K193215, 04/10/2020), among which MR 5300 is specifically predicated to Ingenia Ambition S 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 | | Conclusion: | The proposed MR 5300 is substantially equivalent to the legally marketed predicate device Achieva, Intera, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR systems (K193215, 04/10/2020), among which MR 5300 is specifically predicated to Ingenia Ambition S, 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 proposed MR 5300 meets the acceptance criteria and is adequate for its intended use. | | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The word is written in a bright blue color. The letters are evenly spaced and the overall appearance is clean and professional. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame.