← Product Code [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS) · K031095 # SENSE BODY COIL (K031095) _Philips Medical Systems (Cleveland), Inc. · MOS · Jun 20, 2003 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K031095 ## Device Facts - **Applicant:** Philips Medical Systems (Cleveland), Inc. - **Product Code:** [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS.md) - **Decision Date:** Jun 20, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use The SENSE Body Coil does not change the intended use of the Philips 1.5T Infinion system. The 1.5T Infinion system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, 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 SENSE Body Coil is a receive-only MRI accessory; designed for use with Philips 1.5T Infinion systems. Device consists of flexible, water-resistant housing with Velcro straps; contains two anterior and two posterior antenna loops. Operates as phased array coil; improves signal-to-noise ratio, image resolution, and acquisition time compared to standard body coils. Used in clinical settings by trained physicians/technicians to acquire diagnostic images of soft tissue structures in abdominal, pelvic, and thoracic regions. Output is raw MR signal data processed by the host MRI system into diagnostic images; assists physicians in clinical decision-making and diagnosis. Decoupling achieved via active PIN diodes; tuning/impedance matching is factory-set. ## Clinical Evidence No clinical data. Substantial equivalence is based on bench testing and technical comparison of coil parameters, including signal-to-noise ratio, image resolution, and acquisition time improvements relative to standard body coils. ## Technological Characteristics Receive-only phased array MRI coil; four receive channels. Antenna configuration: two anterior and two posterior loops. Materials: water-resistant fabric housing, flame-rated foam. Decoupling: active PIN diode. Tuning/Impedance: fixed, factory-set. Connectivity: compatible with Philips 1.5T Infinion MRI systems. ## 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 - Phased Array Flexible Cardiac Coil ([K984588](/device/K984588.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # K031095 ## JUN 2 0 2003 ### SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92) #### General Information 1. | Classification: | Class II
Magnetic Resonance Imaging (MRI) Accessory | |-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common/Usual Name: | Magnetic Resonance Imaging (MRI) Coil | | Proprietary Name: | SENSE Body Coil | | Establishment Registration: | Philips Medical Systems
MR PMG Cleveland
595 Miner Road
Highland Heights, Ohio 44143
Contact: Duane C. Praschan
Phone Number: (440) 483-3000
FDA Owner Number: #1217116
FDA Registration Number: #1525965 | | Performance Standards: | Not Applicable. | #### 2. Intended Uses The SENSE Body Coil does not change the intended use of the Philips 1.5T Infinion system. The 1.5T Infinion system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, 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. The SENSE Body Coil is indicated for use in the following anatomic regions and with the designated nuclei: | Anatomic Regions: | Abdominal, pelvic and thoracic. | |-------------------|---------------------------------| | Nuclei Excited: | Hydrogen. | | PHILIPS MEDICAL SYSTEMS | (SBC) | 4/2/03 | I - 1 | |-------------------------|-------|--------|-------| |-------------------------|-------|--------|-------| {1}------------------------------------------------ #### 3. Device Description The SENSE Body Coil is enclosed in a flexible, water-resistant fabric housing and is secured to the patient with Velcro straps. This receive-only coil is designed to give improved signal-to-noise, image resolution and image acquisition time over that of the standard body coil. #### Safety and Effectiveness 4. The Philips SENSE Body Coil is substantially equivalent to the Philips Phased Array Flexible Cardiac Coil (K984588) in safety and effectiveness. The following chart has been compiled to demonstrate this equivalence. | Parameter | SENSE Body Coil | Predicate Device: Phased Array
Flexible Cardiac Coil (K984588) | |-------------------------------|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Compatible MRI
Systems | Same. | Philips 1.5T Infinion Systems | | Mode of Operation | Same. | Receive-Only | | Antenna Configuration | Two anterior loops and
two posterior loops. | Co-rotating saddle coils and loops | | Tuning/Impedance
Matching | Same. | Fixed tuning and matching. Factory
set. | | Method of Decoupling | Same. | Active PIN diode decoupling | | Coil Enclosure | Same. | Flame rated foam and fabric | | Number of Receive
Channels | Same. | Four | | Intended Use | Same. | The 1.5T Infinion system is intended
for use as a NMR device that
produces images that: (1) correspond
to the distribution of protons
exhibiting NMR, (2) depend upon
NMR parameters (proton density,
flow velocity, spin-lattice relaxation
time T1, 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. | {2}------------------------------------------------ | Parameter | SENSE Body Coil | Predicate Device: Phased Array
Flexible Cardiac Coil (K984588) | |---------------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The Flexible Cardiac Coil
is indicated for use in the
following anatomic
regions and with the
designated nuclei: | The Flexible Cardiac Coil is
indicated for use in the following
anatomic regions and with the
designated nuclei: | | | Anatomic Regions:
Abdominal, pelvic and
thoracic regions.
Nuclei Excited: Hydrogen | Anatomic Regions: Heart and
associated structures in the thoracic
region.
Nuclei Excited: Hydrogen. | . {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its wings, symbolizing strength and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" encircles the eagle, indicating the department's name and national affiliation. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 2 0 2003 Mr. Duane C. Praschan Manager, Regulatory Affairs Philips Medical Systems (Cleveland) Inc. 595 Miner Road Cleveland OH 44143 Re: K031095 Trade/Device Name: SENSE Body Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic imaging Regulatory Class: II Product Code: 90 MOS Dated: April 4, 2003 Received: April 30, 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 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. {4}------------------------------------------------ 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. Brogdon Nancy C. Brogdor Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ SENSE Body Coil Device Name: Indications for Use: Intended Use The SENSE Body Coil does not change the intended use of the Philips 1.5T Infinion system. The 1.5T Infinion system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time TI, 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 SENSE Body Coil is indicated for use in the following anatomic regions and with the designated nuclei: Anatomic Regions: Abdominal, pelvic and thoracic regions Hydrogen. Nuclei Excited: (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Daniel A. Szyman Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K031095](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K031095) **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