← Product Code [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS) · K033662 # SYNERGY SPINE ARRAY COIL (K033662) _Philips Medical Systems, Inc. · MOS · Feb 2, 2004 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K033662 ## Device Facts - **Applicant:** Philips Medical Systems, Inc. - **Product Code:** [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS.md) - **Decision Date:** Feb 2, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use The Panorama 0.6T MR Imaging System is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis. ## Device Story Synergy Spine Array (SSA) coil; optional accessory for Panorama 0.6T MR system. Receive-only coil; designed for large imaging volumes or large patients. Operates by detecting hydrogen nuclei signals during MR imaging; transforms signals into images of internal soft tissue structure. Used in clinical settings by trained physicians/technicians. Output interpreted by physicians to assist in diagnosis. Benefits include improved patient handling and capacity to image larger patients compared to standard Body & Spine coils. ## Clinical Evidence Phantom and clinical studies performed. Results demonstrate substantial equivalence to predicate; safety and performance parameters (SNR, uniformity, resolution, etc.) are maintained. ## Technological Characteristics Receive-only MR coil; accessory for Panorama 0.6T system. Designed for thoracic and lumbar spine imaging. Hydrogen nuclei excitation. No specific materials or software algorithm class specified. ## 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 - Integrated Spine Array (ISA) coil for Philips Infinion 1.5T system ## 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}------------------------------------------------ Ko 33662 FEB - 2 2004 # 510(k) Summary (As required by 21CFR 807.92) #### I General Information | Classification: | Class II
Classification Number 90 MOS
Magnetic Resonance Imaging (MRI) Accessory | |-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common/usual name: | Magnetic Resonance Imaging (MRI) Coil | | Proprietary Name: | Synergy Spine Array coil (SSA) | | Predicate device(s): | Integrated Spine Array (ISA) coil for Philips Infinion 1.5T system | | Establishment Registration: | Manufacturer:
Philips Medical Systems MR Technologies Finland, Inc.
Äyritie 4
FI-01510 Vantaa, Finland
Phone: +358 9 2535 9300
Fax: +358 9 2535 9600
FDA Facility Registration #9680194
FDA Owner #1217116

United States Contact:
Philips Medical Systems (Cleveland), Inc.
595 Miner Road
Highland Heights, Ohio 44143
Contact: Duane C. Praschan
Phone: (440) 483-3000
FDA Registration #1525965 | | Performance Standards: | No applicable performance standards have been issued under section 514
of the Food, Drug and Cosmetic Act. | #### Safety and Effectiveness Information Supporting Substantial Equivalence 【】 #### Intended use o The intended use of the Panorama 0.6T SSA coil is to be used in MR imaging of the spine. The Panorama 0.6T system is a whole body scanner and is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2) and (3) display the internal structure of the head, extremities and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination {1}------------------------------------------------ Koszalin 1 sie 2012 of a diagnosis. The SSA coil is indicated for use in the following anatomic regions and with the designated nuclei: Thoracic and Lumbar or spine and sternum Anatomic Regions: Nuclei Excited: Hydrogen ## Device Description The SSA coil is an optional accessory to the Panorama 0.6T MR system. This receiveonly coil is designed for use when large imaging volume is required or when the patient is large or when easy usage is essential. #### Relevant Technological Characteristics ം The technological characteristics of the SSA coil are similar to the predicate ISA coil. The potential benefits associated with the SSA coil include improved patient handling and possibilities to image larger patients than with the Body & Spine coils in the Panorama 0.6T system. ## Safety & Effectivness The SSA coil is substantially equivalent to the Philips ISA Coil in safety and effectiveness. The safety parameters (Static Field, dB/dt, SAR and Acoustic Noise) and the performance parameters (SNR, Image Uniformity, Geometric Distortion, Slice Thickness & Spacing, and Spatial Resolution) for the Panorama 0.6T MR system are unaffected with the SSA coil. #### Substantial Equivalence o Phantom and clinical studies were performed to support the claim of substantial equivalence and to show that the technological differences do not raise new questions pertaining to safety and effectiveness. #### . Conclusion It is the opinion of Philips Medical Systems that the SSA coil of the Panorama 0.6T system is substantially equivalent to the predicate ISA coil of the Philips Infinion 1.5T system. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is a stylized emblem featuring three curved lines that resemble a bird in flight or a symbolic representation of human services. The emblem is positioned diagonally within the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB - 2 2004 Mr. Duane C. Praschan Manager, Regulatory Affairs Philips Medical Systems (Cleveland), Inc. 595 Miner Road HIGHLAND HEIGHTS OH 44143 Re: K033662 Trade/Device Name: Synergy Spine Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: November 18, 2003 Received: November 21, 2003 Dear Mr. Praschan: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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. {3}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Nancy C. Bryden Nancy C. Brogdon Director, Division of Reproductive. Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510(k) Number (if known): __ Ko 3 3 ما جاء 2 #### SYNERGY SPINE ARRAY COIL Device Name: ## Indications for Use: ### Intended Use The Synergy Spine Array Coil does not change the existing indications as defined below. The Panorama 0.6T MR Imaging System is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis. ## Indications for Use The Synergy Spine Array Coil is indicated for use in the following anatomic regions and with designated nuclei: | Anatomic Regions: | Thoracic and lumbar | |-------------------|---------------------| | Nuclei Excited: | Hydrogen | (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use | | |----------------------|--| | (Per 21 CFR 801.109) | | OR | Over-The-Counter Use | | |--------------------------|--| | (Optional Format 1-2-96) | | | (Division Sign-Off) | | |---------------------------------------------------------------|---------| | Division of Reproductive, Abdominal, and Radiological Devices | | | 510(k) Number | K033462 | --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K033662](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K033662) **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