← Product Code [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS) · K032045 # 8 CHANNEL CARDIAC PHASED ARRAY COIL (K032045) _GE Medical Systems · MOS · Jul 30, 2003 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K032045 ## Device Facts - **Applicant:** GE Medical Systems - **Product Code:** [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS.md) - **Decision Date:** Jul 30, 2003 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use It is intended to be used in the heart and mediastinum regions for 2D and 3D Magnetic Resonance imaging. ## Device Story The 8 Channel Cardiac Phased Array Coil is an accessory for Magnetic Resonance Imaging (MRI) systems. It functions as a receiver coil to capture radiofrequency signals from the heart and mediastinum regions during 2D and 3D imaging procedures. The device is a modification of a previously cleared predicate, featuring a flexible anterior coil section to improve patient fit and comfort. It is used in clinical MRI environments by trained radiology technologists or physicians. The output is raw signal data processed by the MRI system to generate diagnostic images, which are interpreted by radiologists to assess cardiac and mediastinal anatomy and pathology. The primary benefit is enhanced image quality and patient comfort during cardiac MRI examinations. ## Clinical Evidence Bench testing only. No clinical data provided. ## Technological Characteristics Phased array MRI receiver coil; 8-channel configuration; flexible anterior section; intended for heart and mediastinum imaging. No specific materials or software algorithms described. ## 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 - 8 Channel Cardiac Phased Array Coil ([K022669](/device/K022669.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/1 description: The image shows the General Electric (GE) logo, which consists of the letters "GE" intertwined within a circle. The letters are stylized with curved lines, giving them a classic and recognizable appearance. The logo is presented in black and white, with the letters and the circle's outline in black against a white background. The overall design is simple yet iconic, representing the long-standing brand identity of General Electric. K032045 Page 1 of 2 GE Medical Systems Page 2 of 2 General Electric Company 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). | Submitter: | GE Medical Systems
PO Box 414
Milwaukee, WI 53201 | |-----------------|---------------------------------------------------------| | Contact Person: | Larry A. Kroger Ph.D.
Manager, Regulatory Programs | | Telephone: | 262- 544-3894 | | Fax: | 262- 548-4768 | | Date Prepared: | June 30, 2003 | #### Device Name: 8 Channel Cardiac Phased Array Coil Magnetic Resonance Coil, 21 CFR 892.1000, 90-MOS ### Marketed Device: The 8 Channel Cardiac Phased Array Coil is substantially equivalent to the currently marketed GE 8 Channel Cardiac Phased Array Coil (K022669). #### Device Description: The 8 Channel Cardiac Phased Array Coil is a modification to the 8 Channel Cardiac Phased Array Coil (K022669), which features a flexible anterior half of the coil. ## Indications for Use: It is intended to be used in the heart and mediastinum regions for 2D and 3D Magnetic Resonance imaging. {1}------------------------------------------------ Image /page/1/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 that resembles a globe. The globe has small, curved lines emanating from the letters, giving the impression of movement or energy. The logo is black and white. Page 2 of 2 K032045 Page 2 of 2 GE Medical Systems General Electric Company P.O. Box 414, Milwaukee, WI 53201 ### Comparison with Predicate Device: The 8 Channel Cardiac Phased Array Coil is a modification of the GE 8 Channel Cardiac Phased Array Coil (K022669) with the main difference being the flexibility of the anterior half of the coil. #### Summary of Studies: Testing was performed to demonstrate that the design modifications to the 8 Channel Cardiac Phased Array Coil meet predetermined acceptance criteria. ### Conclusion: It is the opinion of GE that the 8 Channel Cardiac Phased Array Coil is substantially equivalent to the GE 8 Channel Cardiac Phased Array Coil (K022669). Usage of the 8 Channel Cardiac Phased Array Coil does not result in any new potential hazards. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle with three horizontal lines above it, resembling the stripes of the American flag. The seal is black and white and appears to be of official government origin. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 3 0 2003 Larry Kroger, Ph.D. Regulatory Programs Manager GE Medical Systems General Electric Company P.O. Box 414 MILWAUKEE WI 53201 Re: K032045 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: 90 MOS Dated: June 30, 2003 Received: July 7, 2003 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 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 yours, Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510(k) Number (if known): Device Name: 8 Channel Cardiac Phased Array Coil #### Indications For Use: It is intended to be used in the heart and mediastinum regions for 2D and 3D Magnetic Resonance imaging. ## (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) Over-The-Counter Use_ OR David A. Sezmor Division Sign Off (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K032045](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K032045) **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