← Product Code [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS) · K103365 # DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A (K103365) _Ge Healthcare Coils (Usa Instruments, Inc.) · MOS · Jan 12, 2011 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K103365 ## Device Facts - **Applicant:** Ge Healthcare Coils (Usa Instruments, Inc.) - **Product Code:** [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS.md) - **Decision Date:** Jan 12, 2011 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use The Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch Body Array Coil are receive-only RF Coils designed for use with 3.0T MRI systems manufactured by GE Healthcare. The indications for use include chest, cardiac, abdomen, torso, pelvis, prostate, hips, and long bone imaging. The nucleus detected is hydrogen. ## Device Story Discovery 3T 16 Ch and 32 Ch Body Array Coils are receive-only RF surface coils for 3.0T MRI systems; designed for imaging hydrogen nuclei in chest, cardiac, abdomen, torso, pelvis, prostate, hips, and long bones. Device utilizes 32 phased array elements with integrated preamplifiers to enhance image quality; geometry optimized for parallel imaging. 16-channel version incorporates multiplexers for compatibility with 16-channel systems. Coils feature RF chokes and fast-switching PIN diodes for decoupling during RF transmission. Operated by MRI technicians/radiologists in clinical settings; output is raw RF signal processed by the MRI system into diagnostic images. Benefits include improved signal-to-noise ratio and expanded coverage area compared to previous generation coils, facilitating clinical decision-making through high-resolution anatomical imaging. ## Clinical Evidence Bench testing only. Evidence includes SNR testing and verification of compliance with electrical safety (IEC 60601-1, IEC 60601-2-33), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993-1) standards. ## Technological Characteristics 32-element phased array RF receive-only coils; integrated preamplifiers; RF chokes and fast-switching PIN diodes for decoupling. 16-channel version includes multiplexers. Compliant with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, and ISO 10993-1. Designed for 3.0T 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 - USA Instruments Prima III TotalSENSE Torso Coil ([K030371](/device/K030371.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}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a black and white logo. The logo is circular in shape and contains the letters 'G' and 'E' intertwined in the center. The letters are stylized and appear to be hand-drawn. The logo is surrounded by a thick black border. K103365 ### GE Healthcare 510(k) Premarket Notification Submission ### 510(k) Summary JAN 1 2 2011 In accordance with 21 CFR 807.92 the following summary of information is provided: ト | Date: | November 16, 2010 | |----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | GE Healthcare Coils (USA Instruments, Inc.)
Establishment Registration Number: 1529041
1515 Danner Dr.
Aurora, OH 44202, USA | | Primary Contact Person: | Mr. Michael S. Preto
Regulatory Affairs Leader, MR
GE Healthcare Coils (USA Instruments, Inc.)
Phone: +1 330 995-8333
Fax: +1 330 562-1422
Email: michael.preto@ge.com | | Secondary Contact Person: | Mr. Glen Sabin
Regulatory Affairs Director, MR
GE Healthcare (GE Medical Systems, LLC)
Establishment Registration Number: 2183553
3200 N Grandview Blvd., Mail Code - W-827
Waukesha, WI 53188, USA
Phone: +1 262 521 6848
Fax: +1 262 521 6439
Email: glen.sabin@ge.com | | Device: Trade Name: | Discovery 3T 16 Ch Body Array Coil and
Discovery 3T 32 Ch Body Array Coil | | Common/Usual Name: | Coil, magnetic resonance, specialty | | Classification Names: | 21 CFR 892.1000, Magnetic resonance diagnostic device | | Product Code: | 90MOS | | Predicate Device(s): | K030371, USA Instruments Prima III TotalSENSE Torso Coil | | Device Description: | The Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch Body
Array Coil are surface coils used for Magnetic Resonance Imaging.
They are tuned to image Proton nuclei in a receive-only configuration.
They are comprised of 32 individual Phased Array coil elements each
utilizing an integrated preamplifier to improve image quality. The
geometry is optimized for use with parallel imaging techniques. The 16
Ch version uses multiplexers to allow a 32 channel design to be used on
16 Channel systems. | | Intended Use: | The Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch Body
Array Coil are receive-only RF Coils designed for use with 3.0T MRI
systems manufactured by GE Healthcare. The indications for use include
chest, cardiac, abdomen, torso, pelvis, prostate, hips, and long bone
imaging. The nucleus detected is hydrogen. | | Technology: | The Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch Body
Array Coil are 32-element phased array RF receive only coils with
integrated preamplifiers. The coil designs consist of RF chokes with fast
switching PIN diodes to provide decoupling which isolates the coil
elements from RF fields during RF transmission. This coil is designed
based on the same technology as the predicate device. The 16 Ch version
uses multiplexers to allow a 32 channel design to be used on 16 Channel
systems | | Determination of Substantial
Equivalence: | The Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch Body
Array Coil have comparable indications for use as their predicate device
and the same or similar non-clinical voluntary standards are used to
demonstrate substantial equivalence of safety and performance:
IEC 60601-1: Electrical Safety - compliant with all applicable sections
IEC 60601-1-2: Electromagnetic Compatibility - compliant with all
applicable sections (i.e. electrostatic discharge)
IEC 60601-2-33: Electrical Safety - compliant with all applicable
sections (i.e. documentation requirements)
ISO 10993-1: Biocompatibility - determination of post market
acceptability of materials
SNR testing according to the method identified in Section 18.
The Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch Body
Array Coil have increased channel and larger coverage area than the
TotalSENSE Torso Coil. They share a similar high-level phased array,
receive-only design. | | Conclusion: | GE Healthcare considers the Discovery 3T 16 Ch Body Array Coil and
Discovery 3T 32 Ch Body Array Coil to be as safe, as effective, and
performance is substantially equivalent to the predicate device. | ····· " {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. The letters and the border are in black, contrasting with the white background. . . · - ······· # GE Healthcare GE Healthcare 510(k) Premarket Notification Submission . · . ........ ﺪ {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 Mr. Michael S. Preto Regulatory Affairs Leader-MR GE Healthcare Coils (USA Instruments, Inc.) ' 1515 Danner Drive AURORA OH 44202 JAN 1 2 201 Re: K103365 Trade/Device Name: Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch Body Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: November 16, 2010 Received: November 18, 2010 Dear Mr. Preto: 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of {3}------------------------------------------------ medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Dan David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## K103365 510(k) Number (if known): Device Name: Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch Body Array Coil JAN. 1.2 2011 Indications for Use: The Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch Body Array Coil are receive-only RF Coils designed for use with 3.0T MRI systems manufactured by GE Healthcare. The indications for use include chest, cardiac, abdomen, torso, pelvis, prostate, hips, and long bone imaging. The nucleus detected is hydrogen. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) Page 1 of __ n of Radiologic Office of In Vitro Dia 510K. Page 4-2 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K103365](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K103365) **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