← Product Code [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS) · K041185 # TORSO ARRAY COIL, MODEL 558GE-64 (K041185) _Igc-Medical Advances, Inc. · MOS · May 14, 2004 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K041185 ## Device Facts - **Applicant:** Igc-Medical Advances, Inc. - **Product Code:** [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS.md) - **Decision Date:** May 14, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** 3rd-Party Reviewed ## Intended Use Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the Musculoskeletal structures, soft tissue and vascular structures of the torso, pelvis, and abdomen. ## Device Story Model 558GE-64 Torso Array Coil is an accessory for GE Signa EXCITE 1.5T MR systems; used for 2D/3D imaging, proton density, T1/T2 weighted imaging, time-of-flight, and phase contrast imaging. Coil captures MR signals from chest to pelvic region (liver, spleen, pancreas, gallbladder, peritoneum, renal/adrenal structures, torso vasculature, bladder, uterus, ovaries, prostate). Operated by trained MRI technologists in clinical settings. Output consists of raw MR data processed by the host system into diagnostic images for physician interpretation. Device enhances signal acquisition for anatomical and vascular assessment; does not alter system safety parameters (static field, RF power, acoustic noise). ## Clinical Evidence Bench testing only. No clinical data provided. ## Technological Characteristics MR torso array coil; compatible with GE Signa EXCITE 1.5T systems. Complies with UL 60601-1 and IEC 601-1 safety standards. Materials include UL 94-rated plastics. Passive hardware component; no internal software or active processing algorithms. ## 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. ## Reference Devices - Hitachi AIRIS-Elite 0.3T system ## 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}------------------------------------------------ K041185 # MAY 1 4 2004 : Page 1 of 3 ## 510(k) Summary of Safety and Effectiveness | Device Name | Model 558GE-64 Torso Array Coil | |-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Applicability | Compatible with GE Signa EXCITE 1.5T MR
Systems | | Reason for 510(k) | New device | | Classification Name | Magnetic Resonance Diagnostic Device | | Device Classification Panel | Radiology | | Device Classification Number | 892.1000 | | Product Code | 90MOS | | Common Name | Magnetic Resonance Imaging Coil | | Proprietary Name | Model 558GE-64 Torso Array Coil | | Establishment Registration Number | 2183683 | | Address of MFG Facility | IGC-Medical Advances Inc.
10437 Innovation Drive
Milwaukee, WI 53226 | | Point of Contact | Anthony Dietzler
Quality Assurance Engineer
(414) 258-3808 Ext. 255 | | Classification | Class II | | Intended Uses | | | Diagnostic Uses | 2D, 3D imaging, proton density, T1 and T2
weighted imaging. 2D, 3D time-of-flight, phase
contrast imaging, parallel-imaging compatibility. | | Anatomic Regions | From the chest to the pelvic region - including, but
not limited to the liver, spleen, pancreas,
gallbladder, peritoneum, renal/adrenal structures,
torso vasculature, bladder, uterus, ovaries, and
prostate. | | Maximum Static Magnetic Field: | No change due to coil | | Rate of Magnetic Field Strength Change: | No change due to coil | | RF Power Deposition: | No change | | Acoustic Noise Levels: | No change due to coil | | Biocompatibility: | No change | {1}------------------------------------------------ Koy1185 Page 2 of 3 Standards Performance Standards Voluntary Safety Standards None Established under Section 514 UL 60601-1 Medical Electrical Equipment, Part I: General Requirements for Safety - Tests for Flammability of Plastic UL 94 Materials - General Safety Requirements for IEC 601-1 Medical Electrical Equipment #### Overview The Radiology Devices Panel considered potential concerns regarding the safe and effective operation of Magnetic Resonance Diagnostic Devices when they recommended reclassification to Class II on July 27, 1987. After reclassification, the FDA's Center for Devices and Radiological Health (CDRH) released a draft guidance document for the content and review of Magnetic Resonance Diagnostic Device premarket notification submissions that offered clarification of these concerns. Due to considerable technological advances in MRDDs, CDRH issued an updated guidance document on November 14, 1998. The following is a summary of the information contained within this premarket notification that addresses these concerns: The GE Signa EXCITE 1.5T MRI system, operated with the Medical Advances Torso Array Coil, is substantially equivalent to the Hitachi AIRIS-Elite 0.3T system operated with the legally marketed predicate device listed in section 4.0, within the Class II definition of Magnetic Resonance Diagnostic Device with respect to the safety parameter action levels: #### Safety Parameters {2}------------------------------------------------ K041185 Page 3 of 3 ### Imaging Performance Parameters | Specification Volume: | No change | |-----------------------------------|-----------| | Signal-to-Noise Ratio: | No change | | Image Uniformity: | No change | | Geometric Distortion: | No change | | Slice Thickness and Gap: | No change | | High Contrast Spatial Resolution: | No change | #### General Safety and Effectiveness Concerns The device contains instructions for use. It includes indications for use, precautions, cautions, contraindications, warnings and quality assurance testing. This information assures safe and effective use of the device. #### Substantial Equivalence Summary The GE Signa EXCITE 1.5T MRI system operated with the Medical Advances Torso Array Coil addressed in this PMN, has the same intended use and technological characteristics as the Hitachi AIRIS-Elite 0.3T system operated with the identified legally marketed predicate device. The use of this coil does not affect the GE Signa EXCITE 1.5T system safety parameter specifications. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The text is in all caps and is smaller than the eagle symbol. Food and Drug Administration 9200 Corporate Boulevaid Rockville MD 20850 MAY 1 4 2004 IGC Medical Advances % Mr. Daniel W. Lehtonen Staff Engineer-Medical Devices Intertek Testing Services 70 Codman Hill Road BOXBOROUGH MA 01719 Re: K041185 Trade/Device Name: Model 558GE-64: Torso Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: May 3, 2004 Received: May 6, 2004 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 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {4}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter natification. The FDA finding of substantial equivalence of your device to a legally promance motively 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 11 you accure 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. Broughton Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Page of ﻠﺴ Ko4 1185 510(k) Number (if known): Model 558GE-64: Torso Array Coil Device Name: Indications for Use: Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the Musculoskeletal structures, soft tissue and vascular structures of the torso, pelvis, and abdomen. (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) the text in the image is: and Radiological Dev 510(k) Number --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K041185](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K041185) **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. 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