(10 days)
Not Found
No
The document describes a passive MR imaging coil and does not mention any AI/ML components or image processing capabilities.
No.
The device is a coil for MR imaging, which is a diagnostic tool, not a therapeutic one. It is used to acquire images for diagnosis, not to treat a condition.
No
Explanation: The device is described as a "receive only coil designed for MR imaging" and "designed for MR imaging of general purpose of the human anatomy." Imaging devices are typically used for obtaining images, not for diagnosing conditions themselves. While the images obtained may be used for diagnostic purposes by a clinician, the coil itself is not a diagnostic device.
No
The device description explicitly states it is a "2-turn solenoid receive only coil" with a "soft pad" and connects to an MRI system via an "interface connector," indicating it is a physical hardware component.
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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text clearly describes a receive-only coil for an MRI system. MRI is an imaging modality that uses magnetic fields and radio waves to create images of the inside of the body. It does not involve the analysis of specimens taken from the body.
- Intended Use: The intended use is for "MR imaging" of specific anatomical sites. This is a diagnostic imaging procedure performed directly on the patient, not on a sample.
Therefore, based on the provided information, the GE 0.2T 6-inch GP Coil is a component of an MRI system used for in-vivo imaging, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The GE 0.2T 6-inch GP Coil is a 2-turn solenoid receive only coil designed for MR imaging. The coil has a soft pad, which helps to place the position to be examined in the center of the coil and provides comfort as well. The coil is a general-purpose coil that can be used to image the Cervical Spine, the neck, shoulder, and other extremity anatomy. The coil connects to the Signa MRI system by way of the interface connector.
Product codes (comma separated list FDA assigned to the subject device)
90 MOS
Device Description
The GE 0.2T 6-inch GP Coil is designed for MR imaging of general purpose of the human anatomy. The coil is a 2-turn solenoid coil in series that provides high signal to noise ratio. The coil has blocking networks to decouple the coil during body coil transmit condition.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR imaging
Anatomical Site
Cervical Spine, the neck, shoulder, and other extremity anatomy.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The 0.2T 6-inch GP coil is evaluated to the appropriate NEMA performance standards as well as the IEC 60601-1 International Medical Equipment Safety standard and labeling requirement of IEC 60601-2-33 Particular Requirements for Safety of Magnetic Resonance Equipment for Medical Diagnosis. Testing was performed to demonstrate that the design met predetermined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized and appear to be hand-drawn. The logo is black and white.
GE Healthcare Technologies
P.O. Box 414, Milwaukee, WI 53201
510(K) SUMMARY
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.92(c).
Applicant and Contact Information
| Applicant & Initial Distributor: | GE Healthcare Technologies
3200 N. Grandview Blvd.
Waukesha, WI 53188 |
|----------------------------------|-----------------------------------------------------------------------------|
| Est. Registration No: | 2183553- [per 21 CFR 807.87(b)] |
| Corresponding Official: | Larry A. Kroger, Ph.D. |
| Title: | Senior Regulatory Programs Manager |
| Mailing Address: | GE Healthcare Technologies W-400
P.O. Box 414
Milwaukee, WI 53201 |
| Telephone: | 262-544-3894 |
| Fax: | 262-548-4768 |
| E-mail: | Larry.Kroger@med.ge.com |
Device Name
0.2T 6-inch GP Coil Magnetic Resonance Coil, 21 CFR 892.1000, 90-MOS
Marketed Device
The 0.2T 6-inch receive only GP coil is substantially equivalent to the currently marketed GE Signa Profile 9 inch coil (K972296), which is also a coil for 0.2T MR imaging.
Device Description
The GE 0.2T 6-inch GP Coil is designed for MR imaging of general purpose of the human anatomy. The coil is a 2-turn solenoid coil in series that provides high signal to noise ratio. The coil has blocking networks to decouple the coil during body coil transmit condition.
Indications for Use
The GE 0.2T 6-inch GP Coil is a 2-turn solenoid receive only coil designed for MR imaging. The coil has a soft pad, which helps to place the position to be examined in the center of the coil and provides comfort as well. The coil is a general-purpose coil that can be used to image the Cervical Spine, the neck, shoulder, and other extremity anatomy. The coil connects to the Signa MRI system by way of the interface connector.
1
P.O. Box 414, Milwaukee, WI 53201
Image /page/1/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. The letters and the circle are black, creating a bold and recognizable emblem.
Comparison with Predicate
The predicate device is the GE Signa Profile 9 inch coil (K972296). The coil is a similar design and technology. The main difference is the diameter of the coil.
Summary of Studies
The 0.2T 6-inch GP coil is evaluated to the appropriate NEMA performance standards as well as the IEC 60601-1 International Medical Equipment Safety standard and labeling requirement of IEC 60601-2-33 Particular Requirements for Safety of Magnetic Resonance Equipment for Medical Diagnosis. Testing was performed to demonstrate that the design met predetermined acceptance criteria.
Conclusion:
It is the opinion of GE that the 0.2T 6-inch GP Coil is substantially equivalent to the GE Signa Profile 9 inch coil (K972296). The GE 0.2T 6 inch GP Coil includes all the indications for use of that of the predicate device. The use of this device will not result in any new potential hazards.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 6 2004
Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems, LLC GE Healthcare Technologies P.O. Box 414, W-400 MILWAUKEE WI 53201
Re: K041921
Trade/Device Name: GE 0.2T 6 inch GP coil Regulatory Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II
Product Code: 90 MOS Dated: July 15, 2004 Received: July 16, 2004
Dear Dr. Kroger:
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 such 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 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 vours,
Nancy C. Brygdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular shape. The circle is surrounded by a pattern of swirling lines, creating a dynamic and recognizable emblem for the company.
GE Healthcare Technologies P.O. Box 414, Milwaukee, WI 53201
STATEMENT OF INTENDED USE
510(k) Number (if known): _Ko4 /92 /
Device Name: 0.2T 6-inch GP Coil
Indications for Use:
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(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
E-2
Over-The-Counter Use
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,and Radiological Devices 510(k) Number