(56 days)
Not Found
No
The summary describes a receive-only RF coil for MRI, focusing on hardware components, coil elements, and parallel imaging techniques. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML.
No.
The device is described as a receive-only RF coil used for Magnetic Resonance Imaging, with indications for imaging various anatomical sites. Its function is to acquire image data, not to provide therapy or treatment.
No
The device is described as an RF coil used for imaging (Magnetic Resonance Imaging), specifically for capturing images. While imaging can be part of a diagnostic process, the device itself is a tool for image acquisition, not for making a diagnosis or providing diagnostic interpretations. It produces data (images) that can then be used by a clinician for diagnosis.
No
The device description explicitly states it is comprised of physical components like "surface coils," "Phased Array coil elements," and "integrated preamplifier," indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The description clearly states that this device is an RF coil used for Magnetic Resonance Imaging (MRI). MRI is an imaging technique that uses magnetic fields and radio waves to create images of the inside of the body. It does not involve testing specimens taken from the body.
- Intended Use: The intended use is for imaging various anatomical sites within the body.
Therefore, based on the provided information, the Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch Body Array Coil are medical devices used for imaging, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
90MOS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
chest, cardiac, abdomen, torso, pelvis, prostate, hips, and long bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
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).(b)
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.
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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.
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. |
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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.
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GE Healthcare GE Healthcare
510(k) Premarket Notification Submission
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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)
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n of Radiologic Office of In Vitro Dia 510K.
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