(29 days)
Not Found
No
The description focuses on the physical design and technical specifications of an MRI coil, with no mention of AI or ML for image processing, analysis, or any other function.
No
The device is a receive-only RF coil for an MRI system, designed for imaging purposes (diagnosis), not for treating or preventing disease.
No
This device is an RF coil for an MRI system, designed to acquire image data. It does not analyze or interpret the data to diagnose a condition. The MRI system itself, in conjunction with a trained professional, is used for diagnosis.
No
The device description explicitly details physical hardware components (RF coil, coil elements, preamplifiers, chokes, switching diodes) and their physical design and function. It is a hardware device used in conjunction with an MRI system.
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 for diagnosis, monitoring, or screening.
- Device Function: The GE 3.0T 16 Channel Head Neck Spine Coil is an MRI coil. It's a component of an MRI system used to receive radiofrequency signals from the patient's body during an MRI scan. This process is in vivo (within the living body), not in vitro (outside the living body).
- Intended Use: The intended use clearly states it's for "imaging of the brain; cervical, thoracic, and lumbar spines; as well as the soft tissues and vasculature of the head, neck, and upper chest." This is a description of a medical imaging procedure performed directly on a patient.
Therefore, based on the provided information, this device is a medical imaging accessory used in an in vivo procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The GE 3.0T 16 Channel Head Neck Spine Coil is a receive-only RF coil designed for use with the 3.0T MRI system manufactured by GE Healthcare. The coil is intended for imaging of the brain; cervical, thoracic, and lumbar spines; as well as the soft tissues and vasculature of the head, neck, and upper chest. The nucleus excited is hydrogen.
Product codes
90MOS
Device Description
The 3.0T Head Neck and Spine Coil is a receive-only 16-channel, 29-element coil designed for use with GE 3.0T MRI Systems. This rigid coil incorporates soft, flexible components that conform to patients' anatomy, accommodating various body contours while minimizing patient discomfort.
The Head, Neck and Spine Array (HNS) coil is comprised of 4 units: the Head/ Neck Unit (HNU), the Thoracic/ Lumbar unit (TLU) and the Neck Chest Unit (NCU) and Horseshoe.
The 3.0T HNS Coil has an array of 21 coil elements in the head neck units and 8 coil elements in the Spine Unit. Twelve coil elements cover the head region. Another four coil elements cover the lower neck and Brachial Plexus regions. Five coil elements cover the upper neck and the chest region. The Spine Unit has an array of 8 coil elements, which cover the thoracic and lumbar spine regions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
brain; cervical, thoracic, and lumbar spines; soft tissues and vasculature of the head, neck, and upper chest.
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
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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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GE Healthcare
Image /page/0/Picture/2 description: The image shows a black and white logo. The logo is circular and contains the letters 'G' and 'E' intertwined. The letters are stylized and have a cursive appearance. The logo is likely for General Electric.
NOV 2 5 2009
3.0T 16 Channel Head Neck Spine Coil 510(k) Premarket Notification
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
Date: July 1st, 2009
Submitter: GE Healthcare Coils (USA Instruments Inc.) Establishment Registration Number: 1529041 1515 Danner Dr., Aurora, OH - 44202-9273 USA
Primary Contact Person: Elizabeth Mathew Regulatory Affairs Leader GE Healthcare (GE Medical Systems LLC.) Establishment Registration Number: 2183553 3200 N Grandview Blvd., Mail Code - W-827 Waukesha, WI - 53188 USA Phone: 262-521-6658 Fax: 262-521-6439
Secondary Contact Person: Glen Sabin
Regulatory Affairs Manager GE Healthcare (GE Medical Systems LLC.) Establishment Registration Number: 2183553 3200 N Grandview Blvd., Mail Code - W-827 Waukesha, WI -- 53188 . USA Phone: 262-521-6848 Fax: 262-521-6439
Device:
Trade Name: 3.0T 16 Channel Head Neck Spine Coil
Common/Usual Name: 3.0T HNS Coil
1
GE Healthcare
Image /page/1/Picture/14 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular border. The letters and the border are in black, contrasting with the white background.
3.0T 16 Channel Head Neck Spine Coil 510(k) Premarket Notification
Classification Names: 21 CFR 892.1000
Product Code: 90MOS
Predicate Device(s): (1) 3.0T 16 Channel Brain/Spine (Neurovascular) Array Coil (K052916)
(2) 1.5T 16 Channel Brain/Spine Coil (K052612)
The 3.0T Head Neck and Spine Coil is a receive-only 16-channel, Device Description: 29-element coil designed for use with GE 3.0T MRI Systems. This rigid coil incorporates soft, flexible components that conform to patients' anatomy, accommodating various body contours while minimizing patient discomfort.
The Head, Neck and Spine Array (HNS) coil is comprised of 4 units: the Head/ Neck Unit (HNU), the Thoracic/ Lumbar unit (TLU) and the Neck Chest Unit (NCU) and Horseshoe.
The 3.0T HNS Coil has an array of 21 coil elements in the head neck units and 8 coil elements in the Spine Unit. Twelve coil elements cover the head region. Another four coil elements cover the lower neck and Brachial Plexus regions. Five coil elements cover the upper neck and the chest region. The Spine Unit has an array of 8 coil elements, which cover the thoracic and lumbar spine regions.
Intended Use: The GE 3.0T 16 Channel Head Neck Spine Coil is a receive-only RF coil designed for use with the 3.0T MRI system manufactured by GE Healthcare. The coil is intended for imaging of the brain; cervical, thoracic, and lumbar spines; as well as the soft tissues and vasculature of the head, neck, and upper chest. The nucleus excited is hydrogen.
The 3.0T 16 Channel Head Neck Spine Coil is a multi-element Technology: phased array RF Receive only coil with integrated preamplifiers. The coil design consists of RF chokes with switching 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 devices.
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Image /page/2/Picture/1 description: The image shows a partial view of the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The image is in black and white, with the logo appearing in black against a white background.
3.0T 16 Channel Head Neck Spine Coil 510(k) Premarket Notification
KU433
5.01 10 Channel Head Neck Spine Co
510(k) Premarket Notification
Determination of The 3.0T 16 Channel Head Neck Spine Coil has the same Substantial Equivalence: indications for use as the predicate devices.
Comparison with 3.0T 16 Channel Brain/Spine Coil
The 3.0T 16 Channel Head Neck Spine Coil is a new device which is similar in design to the existing 3.0T 16 Channel Brain/Spine Coil (K052916).
Comparison with 1.5T 16 Channel Brain/Spine Coil
The 3.0T 16 Channel Head Neck Spine Coil is a new device which is similar to the existing 1.5T 16 Channel Brain/Spine Coil (K052621) with the primary difference being the strength of the static magnetic field of the system that the coil is compatible with and hence adjustments to the corresponding frequency specific components.
Conclusion:
GE Healthcare considers the 3.0T 16 Channel Head Neck Spine (HNS) Coil to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).
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Image /page/3/Picture/0 description: The image shows the logo of the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter of the circle.
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
NOV 2 5 2009
GE Healthcare Coils (USA Instruments, Inc.) % Mr. Daniel W. Lehtonen Official Correspondent Intertek Testing Services NA, Inc. 2307 E. Aurora Rd., Unit B7 TWINSBURG OH 44087
- Re: K093348
- Trade/Device Name: 3.0T 16 Channel Head Neck Spine Coil Regulation Number: 21 CFR 892.1000
- Regulation Name: Magnetic resonance diagnostic device
- Regulatory Class: II
- Product Code: MOS
- Dated: October 26, 2009 Received: October 27, 2009
Dear Mr. Lehtonen:
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. Ilsting 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); medical device reporting (reporting of medical '
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device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris Acting Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. The letters are stylized with curved lines and a vintage design, and the logo is presented in black and white.
3.0T 16 Channel Head Neck Spine Coil 510(k) Premarket Notification
K093348 510(k) Number (if known):
Device Name:
3.0T 16 Channel Head Neck Spine Coil
Indications for Use:
The GE 3.0T 16 Channel Head Neck Spine Coil is a receive-only RF coil designed for use with the 3.0T MRI system manufactured by GE Healthcare. The coil is intended for imaging of the brain; cervical, thoracic and lumbar spines; as well as the soft tissues and vasculature of the head, neck, and upper chest. The nucleus excited is hydrogen.
Prescription Use_X____________________________________________________________________________________________________________________________________________________________ Use (Part 21 CFR 801 Subpart D)
Over-The-Counter
(Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aram Mrohy
(Division S n-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number
4-2