← Product Code [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS) · K033235 # GEMINI III HYBRID TX/RX 4 CHANNEL HEAD COIL (K033235) _Usa Instruments, Inc. · MOS · Dec 17, 2003 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K033235 ## Device Facts - **Applicant:** Usa Instruments, Inc. - **Product Code:** [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS.md) - **Decision Date:** Dec 17, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use The Gemini III Hybrid Tx/Rx 4 Channel Head Coil consists of a transmit birdcage coil and a receive only 4 channel phased array RF coil, used for obtaining diagnostic images of the brain, cervical spine, soft tissue of the neck and upper chest in Magnetic Resonance Imaging Systems. The Gemini III Hybrid Tx/Rx 4 Channel Head Coil is compatible with SENSE technology and designed for use with the Allegra 3.0T MRI systems manufactured by Siemens Medical Solutions. ## Device Story The Gemini III Hybrid Tx/Rx 4 Channel Head Coil is an MRI accessory designed for use with Siemens Allegra 3.0T MRI systems. It features a transmit birdcage coil and a receive-only 4-channel phased array coil housed in a rigid, flame-retardant plastic enclosure. The device is used in clinical MRI settings to obtain diagnostic images of the brain, cervical spine, and neck/upper chest soft tissues. It utilizes active and passive switching diodes for decoupling and RF isolation to prevent RF burns. The coil is compatible with SENSE technology. Power deposition is managed by the host MRI system's SAR algorithm. The device is operated by trained MRI technicians or radiologists; the resulting images are interpreted by physicians to assist in clinical diagnosis. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Rigid flame-retardant polyurethane enclosure; transmit birdcage coil; 4-channel receive-only phased array; active/passive switching diodes for decoupling; compatible with SENSE technology; designed for 3.0T MRI systems; SAR-limited power deposition. ## 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 - Magnetom Trio 3.0T Head Coil ([K021262](/device/K021262.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}------------------------------------------------ Ko3 3235 ## DEC 17 2003 . ## SUMMARY OF SAFETY AND EFFECTIVENESS | 1. Device Name: | Magnetic Resonance Imaging Accessory | |-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 2. Proprietary Name: | Gemini III Hybrid Tx/Rx 4 Channel Head Coil | | 3. Classification: | Class II | | 4. Establishment Registration #: | 1529041 | | 5. Manufacture Facility Location: | USA Instruments, Inc.
1515 Danner Drive
Aurora, Ohio 44202, USA
Telephone: 330-562-1000; Fax: 330-562-1422. | | 6. Performance Standard: | No applicable performance standards have been
issued under Section 514 of the Food, Drug and
Cosmetic Act. | | 7. Intended Use: | The Gemini III Hybrid Tx/Rx 4 Channel Head Coil
consists of a transmit birdcage coil and a receive
only 4 channel phased array RF coil, used for
obtaining diagnostic images of the brain, cervical
spine, soft tissue of the neck and upper chest in
Magnetic Resonance Imaging Systems. The Gemini
III Hybrid Tx/Rx 4 Channel Head Coil is compatible
with SENSE technology and designed for use with
the Allegra 3.0T MRI systems manufactured by
Siemens Medical Solutions. | | 8. Device Description: | The Gemini III Hybrid Tx/Rx 4 Channel Head Coil
consists of a transmit birdcage coil and a receive
only 4 channel phased array RF coil. The coil has a
rigid enclosure. The open, patient friendly design
eases patient handling and positioning and
maximizes patient comfort. The coil elements and
accessory electronics are enclosed in a rigid plastic
housing, which is fire rated and has a high impact
and tensile strength. | {1}------------------------------------------------ ## 9. Safety and Effectiveness | Gemini III Hybrid Tx/Rx 4 Channel Head
Coil product features | Comparison to predicate device or other 510(k)
cleared products | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------| | Intended Use: Imaging of the brain,
cervical spine, soft tissue of the head
and neck, | -Similar to the Magnetom Trio 3.0T Head Coil
manufactured by USA Instruments, Inc. (K021262) | | Indications for Use: Identical to routine
MRI imaging | -Similar to the Magnetom Trio 3.0T Head Coil
manufactured by USA Instruments, Inc. (K021262) | | Coil Enclosure Material:
Flame Retardant Polyurethane | -Similar to the Magnetom Trio 3.0T Head Coil
manufactured by USA Instruments, Inc. (K021262) | | Coil Design: The coil design consists of a
transmit birdcage coil and a receive only
phased array coil. | -Similar to the Magnetom Trio 3.0T Head Coil
manufactured by USA Instruments, Inc. (K021262) | | Decoupling: active and passive switching
diodes | -Similar to the Magnetom Trio 3.0T Head Coil
manufactured by USA Instruments, Inc. (K021262) | | Prevention of RF Burns: The coil uses pin
diodes to isolate the receive elements from
the transmit coil; coil elements and circuitry
are enclosed in a non-conductive housing | -Similar to the Magnetom Trio 3.0T Head Coil
manufactured by USA Instruments, Inc. (K021262) | | Radio Frequency Absorption: Power
deposition during imaging is limited by SAR
algorithm | -Similar to the Magnetom Trio 3.0T Head Coil
manufactured by USA Instruments, Inc. (K021262) | | Formation of Resonant Loop: Active
diodes isolate the coil elements from RF
fields: length of cable and stiffness does not
permit looping | -Similar to the Magnetom Trio 3.0T Head Coil
manufactured by USA Instruments, Inc. (K021262) | . {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## DEC 17 2003 Ms. Christie Shumaker Manager, QA and Regulatory USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202 Re: K033235 Trade/Device Name: Gemini III Hybrid Tx/Rx 4 Channel Head Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: September 29, 2003 Received: October 6, 2003 Dear Ms. Shumaker: 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 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): K033235 Device Name: Gemini III Hybrid Tx/Rx 4 Channel Head Coil Indications for Use: The Gemini III Hybrid Tx/Rx 4 Channel Head Coil is designed to provide Magnetic Resonance Images of the brain, upper cervical spine, and the soft tissues and vasculature of the head and neck. The Gemini III Hybrid Tx/Rx 4 Channel Head Coil is designed for use with the Siemens Allegra 3.0T scanner manufactured by Siemens Medical Solutions, Inc. > Anatomic Regions: brain, upper cervical spine, and the soft tissues and vasculature of the head and neck Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The 3.0T MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis. (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 | Over-The-Counter Use (Optional Format 1-2-96) | |---------------------------------------|----------------------------------------|----|-----------------------------------------------| |---------------------------------------|----------------------------------------|----|-----------------------------------------------| | (Division Sign-Off) | Nancyc Brogdon | |---------------------------------------------------------------|-----------------------| | Division of Reproductive, Abdominal, and Radiological Devices | | | 510(k) Number | K033235 | --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K033235](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K033235) **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