(22 days)
Not Found
No
The summary describes a passive RF coil for MRI, which is a hardware component. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
No
The device is a receive-only RF Coil used for magnetic resonance imaging, which is a diagnostic imaging technique, not a therapeutic procedure.
No.
Explanation: The device is an RF coil for MRI systems, described as receive-only for imaging. Its purpose is to acquire images, not to interpret or diagnose from them.
No
The device is described as a physical "surface coil" comprised of "individual Phased Array coil elements" and "integrated preamplifier," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- 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 detailed images of organs and tissues inside the body. It does not involve testing samples taken from the body.
- Intended Use: The intended use is for imaging the heart, mediastinum, and pelvis regions for 2D and 3D Magnetic Resonance imaging. This is a diagnostic imaging procedure, not an in vitro diagnostic test.
Therefore, this device falls under the category of medical imaging equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The 8 Channel Cardiac Phased Array Coil is a receive-only RF Coil designed for use with 1.5T MRI systems manufactured by GE Healthcare. The indications for use include imaging of the heart, mediastinum, and pelvis regions for 2D and 3D Magnetic Resonance imaging. The nucleus excited is hydrogen.
Product codes
90MOS
Device Description
The 8 Channel Cardiac Phased Array Coil is a surface coil used for Magnetic Resonance Imaging. It is tuned to image Proton nuclei in a receive-only configuration. It is comprised of individual Phased Array coil elements each utilizing an integrated preamplifier to improve image quality. The geometry is optimized for use with parallel imaging techniques.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
heart, mediastinum, and pelvis regions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined within a circle. The letters are stylized and connected, creating a recognizable and iconic symbol for the company.
KIDI492
510(k) Premarket Notification Submission
JUN 2:3 2010
510(k) Summary
| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|---|---|
| Date: | April 6, 2010 |
| Submitter: | GE Healthcare Coils (USA Instruments, Inc.) |
| 1515 Danner Dr. | |
| Aurora, OH 44202 | |
| Primary Contact Person: | Mr. Michael S. Preto |
| Regulatory Affairs Leader, MR | |
| GE Healthcare Coils (USA Instruments, Inc.) | |
| +1 330 995-8333 | |
| +1 330 562-1422 | |
| 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: 262-521-6848 | |
| Fax: 262-521-6439 | |
| Device: Trade Name: | 8 Channel Cardiac Phased 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): | (1) K032045, 8 Channel Cardiac Phased Array Coil |
| (2) K052584, 1.5T 12 Channel Body Array | |
| Device Description: | The 8 Channel Cardiac Phased Array Coil is a surface coil used |
| for Magnetic Resonance Imaging. It is tuned to image Proton | |
| nuclei in a receive-only configuration. It is comprised of | |
| individual Phased Array coil elements each utilizing an integrated | |
| preamplifier to improve image quality. The geometry is | |
| optimized for use with parallel imaging techniques. | |
| Intended Use: | The 8 Channel Cardiac Phased Array Coil is a receive-only RF |
| Coil designed for use with 1.5T MRI systems manufactured by | |
| GE Healthcare. The indications for use include imaging of the | |
| heart, mediastinum, and pelvis regions for 2D and 3D Magnetic | |
| Resonance imaging. The nucleus excited is hydrogen. |
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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is black and white, with the letters and border appearing in black against a white background.
K101492
page 2/2
GE Healthcare 510(k) Premarket Notification Submission
The 8 Channel Cardiac Phased Array Coil has not been modified Technology: to accommodate the new anatomical region.
Determination of Substantial Equivalence:
The 8 Channel Cardiac Phased Array Coil has comparable indications for use as its predicate devices:
Comparison with original & Channel Cardiac Phased Array Coil submission (K32045):
The 8 Channel Cardiac Phased Array Coil has not been modified to accommodate the new anatomical region.
Comparison with 1.5T 12 Channel Body Array Coil (K052584):
The 8 Channel Cardiac Phased Array Coil is an existing device which will now have indications for use that are similar to the existing 1.5T 12 Channel Body Array Coil.
GE Healthcare considers the 8 Channel Cardiac Phased Array Conclusion: Coil to be as safe, as effective, and performance is substantially equivalent to the predicate devices.
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 stripes extending from its back, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Roon1 - WO66-G609 Silver Spring, MD 20993-0002
JUN 2 3 2010
GE Healthcare Coils (USA Instruments, Inc.) % Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services 2307 E. Aurora Rd., Unit B7 TWINSBURG OH 44087
Re: K101492
Trade/Device Name: 8 Channel Cardiac Phased Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: May 28, 2010 Received: June 1, 2010
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, 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 (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) 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,
Donald J. Trump
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name:
8 Channel Cardiac Phased Array Coil
Indications for Use:
The 8 Channel Cardiac Phased Array Coil is a receive-only RF Coil designed for use with 1.5T MRI systems manufactured by GE Healthcare. The indications for use include imaging of the heart, mediastinum, and pelvis regions for 2D and 3D Magnetic Resonance imaging. The nucleus excited 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)
Robert H. Baker
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K10/4/92
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