← Product Code [MOS](/productcode/MOS) · K013894 # TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T (K013894) _Philips Medical Systems North America, Inc. · MOS · Jan 18, 2002 · Radiology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K013894 ## Device Facts - **Applicant:** Philips Medical Systems North America, Inc. - **Product Code:** [MOS](/productcode/MOS.md) - **Decision Date:** Jan 18, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Indications for Use The indication for use for the Transmit/Receive Quadrature Body Coil 3.0T expands the INTERA 3.0T system capability as a diagnostic device that produces transverse, sagittal, coronal and oblique cross-sectional images based upon 'H metabolites, and that displays the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis ## Device Story Transmit/Receive Quadrature Body Coil 3.0T is a bird-cage type RF coil for the Philips INTERA 3.0T MRI system; fixed position inside gradient coil. Functions in transmit mode for scanning and receive mode for large field-of-view imaging. Enables whole-body scanning capability for the INTERA 3.0T system, previously limited to head scanning. Operated by trained MRI technicians/physicians in clinical settings. Output consists of cross-sectional images (transverse, sagittal, coronal, oblique) displayed for physician interpretation to assist in clinical diagnosis. ## Clinical Evidence Bench testing only. No clinical data provided. ## Technological Characteristics Bird-cage type transmit/receive RF coil; fixed position inside gradient coil. Designed for 3.0T MRI systems. Complies with NEMA voluntary standards, FDA MRDD guidance, UL, and IEC 601 safety standards. ## 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 - Quadrature Body Coil used with the INTERA 1.5T system ([K001796](/device/K001796.md)) ## Reference Devices - Philips INTERA 3.0T System ([K003516](/device/K003516.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}------------------------------------------------ KO1 3894 Philips Medical Systems PMG Magnetic Resonance XJR-148-4750/bf 2001-11-16 # JAN 1 8 2002 Page 1 of 2 ### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS The following information is being submitted in accordance with the requirements of 21 CFR 807.92. #### General information | Company Name | : Philips Medical Systems North America Company. | |-----------------------|-------------------------------------------------------------------------------------------------------------------------------------| | Address | : 22100 Bothell Everett Highway
P.O. Box 3003 | | Registration No. | : Bothell, WA 98041-3003 | | Contact person | : Lynn Harmer | | Device (Trade) Name | : Transmit/Receive Quadrature Body Coil 3.0T. | | Classification Name | : Magnetic Resonance Diagnostic Device (MRDD). | | Classification | : Class II. | | Product code | : MOS | | Performance standards | : NEMA voluntary standards, FDA MRDD guidance's, UL
and IEC 601 appropriate safety standards and/or draft
standards are used. | | Common/Usual Name | : Transmit/Receive Quadrature Body Coil 3.0T | #### Predicate Device(s): The Transmit/Receive Quadrature Body Coll 3.0T is an extension to the MRDD Philips INTERA 3.0T System (re K003516). The Transmit/Receive Quadrature Body Coil 3.0T is equivalent to Quadrature Body Coil used with the INTERA 1.5T system. #### Indications for use: The indication for use for the Transmit/Receive Quadrature Body Coil 3.0T expands the INTERA 3.0T system capability as a diagnostic device that produces transverse, sagittal, coronal and oblique cross-sectional images based upon 'H metabolites, and that displays the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis #### Device description: The Transmit Receive Quadrature Body Coil 3.0T is a bird-cage type transmit/receive coil designed for use in the Intera 3.0T system. In transmit mode the coil is used in almost every kind of scan. In receive mode the coil is mainly used for imaging with a large field of view. The QBC has a fixed position inside the gradient coil . {1}------------------------------------------------ Page 2 of 2 # General Safety and Effectiveness. The safety of the INTERA 3.0T system with the Transmit/Receive Quadrature Body Coil 3.0T remain the same as with the FDA cleared INTERA 1.5T (re. K001796).The Transmit/Receive Quadrature Body Coil 3.0T permits the INTERA 3.0T system to be used as a whole body scanner. It was distributed as a head scanner only. The QBC 3.0T does not result in any new potential hazard. ## Substantial Equivalence. It is the opinion of Philips Medical Systems that the Transmit/Receive Quadrature Body Coil 3.0T is substantially equivalent to its predicate device quadrature body coil used in the INTERA 1.5T (re.K001796) {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 'JAN 1 8 2002 Ms. Lynn Harmer Manager, Regulatory Submissions Philips Medical Systems 22100 Bothell Everett Highway BOTHELL WA 98021-8431 Re: K013894 Trade/Device Name: Transmit/Receive Quadrature Body Coil 3.0T System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: November 21, 2001 Received: November 23, 2001 Dear Ms. Harmer: 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. {3}------------------------------------------------ This letter will allow you to begin marketing your device as described in your 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 this 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" (21 CFR Part 807.97). 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. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Page 1 of 1. 510(k) Number (if known): Kol 3894 Device Name : Transmit/Receive Quadrature Body Coil 3.0T Indication For Use : The indication for use for the Transmit/Receive Quadrature Body Coil 3.0T expands the INTERA 3.0T system capability as a diagnostic device that produces transverse, sagittal, coronal and oblique cross-sectional images based upon 'H metabolites, and that displays the internal structure of the whole body. These images when interpreted by a trained physician, vield information that may assist in diagnosis # ( 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) Nancy C. Burgdon and Rac 510(k) Num --- **Source:** [https://fda-staging.innolitics.com/device/K013894](https://fda-staging.innolitics.com/device/K013894) **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. 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