32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch

Q: Who is the manufacturer of 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch?

Neocoil, LLC filed the 510(k) submission for 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch (K213687).

Q: What is the FDA product code for 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch?

MOS. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

Q: What is the regulatory pathway for 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch?

3.0T GEM RT Open Array (K143389).

Q: Who can help prepare an FDA 510(k) submission like 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K213687 · Neocoil, LLC · MOS · Mar 11, 2022 · Radiology

Device Facts

Record ID	K213687
Device Name	32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch
Applicant	Neocoil, LLC
Product Code	MOS · Radiology
Decision Date	Mar 11, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2

Intended Use

The 32Ch AIR Open Coil Suite are Magnetic Resonance Imaging (MRI) RF Receive-Only Coils intended to be used by trained medical professionals, for adult patients, in combination with and controlled by 1.5T or 3.0T GE Healthcare MRI system software. The 32Ch AIR Open Coil Suite is intended for use with specified couchtop and patient immobilization devices depending on the region of interest. When used as intended, the 32Ch AIR Open Coil Suite is used to produce diagnostic images of the head, neck, and brachial plexus structures. The images can be interpreted by medical professionals or facilitate Radiation Therapy (RT) planning.

Device Story

32Ch AIR Open Coil Suite consists of receive-only phased array RF coils (1.5T and 3.0T variants) for head, neck, and brachial plexus imaging; used with GE Healthcare MRI scanners. Coils receive magnetic resonance signals from hydrogen nuclei; signals amplified and transferred to scanner for tomographic image reconstruction. Operated by trained medical professionals in clinical settings. Used with couchtop/immobilization devices for patient positioning. Output images used for diagnostic interpretation or RT planning. Benefits include improved SNR and uniform anatomical coverage.

Clinical Evidence

Clinical performance evaluation conducted to assess image quality across 1.5T and 3.0T field strengths. No adverse events reported. Bench testing included biocompatibility, electrical safety (IEC 60601-1, 60601-2-33, 60601-1-2), surface temperature, and NEMA MS 6-2008 compliance for SNR and image uniformity. Results demonstrate performance consistent with predicate.

Technological Characteristics

Receive-only phased array RF coils; 1.5T and 3.0T field strengths. Materials assessed for biocompatibility. Energy source: MRI scanner (no internal power). Connectivity: System cable to GE Healthcare MRI scanner. Standards: IEC 60601-1, 60601-2-33, 60601-1-2, NEMA MS 6-2008.

Indications for Use

Indicated for adult patients requiring diagnostic MRI imaging of head, neck, and brachial plexus structures, or for Radiation Therapy (RT) planning, using 1.5T or 3.0T GE Healthcare MRI systems.

Regulatory Classification

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

3.0T GEM RT Open Array (K143389)

Related Devices

K143389 — 3.0T GEM RT Open Array · Ge Healthcare Coils (Usa Instruments, Inc.) · Mar 6, 2015
K253738 — 3.0T AIR 32CH HNA · Ge Healthcare Coils (Usa Instruments, Inc.) · Jan 23, 2026
K123327 — 1.5T GEM RT OPEN ARRAY · Ge Healthcare Coils (Usa Instruments, Inc.) · Jan 11, 2013
K984257 — MEDRAD PHASED ARRAY NEUROVASCULAR COIL · Medrad, Inc. · Jan 25, 1999
K072909 — 1.5T 32-CHANNEL HEAD COIL AND 3T 32-CHANNEL HEAD COIL · Siemens AG Medical Solutions · Oct 31, 2007

Submission Summary (Full Text)

{0}------------------------------------------------ March 11, 2022 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. NeoCoil, LLC % Katie Gonzalez Quality Systems and Regulatory Manager N27 W23910A Paul Road PEWAUKEE WI 53072 ## Re: K213687 Trade/Device Name: 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: MOS Dated: February 23, 2022 Received: February 24, 2022 Dear Katie Gonzalez: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213687 #### Device Name 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Oven Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch #### Indications for Use (Describe) The 32Ch AIR Open Coil Suite are Magnetic Resonance Imaging (MRI) RF Receive-Only Coils intended to be used by trained medical professionals. for adult patients, in combination with and controlled by 1.5T or 3.0T GE Healthcare MRI system software. The 32Ch AIR Open Coil Suite is intended for use with specified couchtop and patient immobilization devices depending on the region of interest. When used as intended, the 32Ch AIR Open Coil Suite is used to produce diagnostic images of the head, neck, and brachial plexus structures. The interpreted by medical professionals or facilitate Radiation Therapy RT planning. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for NeoCoil. To the left of the company name is a black circular design with a white crescent shape inside. The company name is written in a sans-serif font, with "Neo" in blue and "Coil" in black. ## Traditional 510(k) Summary Applicant NeoCoil, LLC N27 W23910A Paul Rd Pewaukee, WI 53072 USA Contact Katie Gonzalez Quality Systems and Regulatory Manager 262-522-6124 (office) 262-347-1251 (fax) Katie.Gonzalez@neocoil.com Preparation Date November 18, 2021 Name of Device - . Trade/Proprietary name(s): 32Ch AIR Open Coil Suite 1.5T 32Ch AIR Open Coil Suite 1.5T AIR Open Head Neck Posterior 9ch 1.5T AIR Open Neck Chest Anterior 7ch 1.5T AIR Open Head Anterior 16ch 3.0T 32Ch AIR Open Coil Suite 3.0T AIR Open Head Neck Posterior 9ch 3.0T AIR Open Neck Chest Anterior 7ch 3.0T AIR Open Head Anterior 16ch - Common name: Magnetic Resonance Specialty Coil - . Classification name: 21 CFR 892.1000, Magnetic resonance diagnostic device, Product Code MOS Predicate Device 3.0T GEM RT Open Array, K143389 cleared on 03/06/2015 Device Description The 32Ch AIR Open Coil Suite is comprised of MRI receive-only phased array RF coils designed for clinically acceptable signal-to-noise ratio (SNR) and uniform coverage of the Head, Neck and Brachial Plexus anatomy for use with GE Healthcare Magnetic Resonance Imaging (MRI) {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for NeoCoil. The logo consists of a black circular shape with an arrow pointing to the right, followed by the word "NeoCoil" in blue and black. The word "Neo" is in blue, while the word "Coil" is in black. scanners. The 32Ch AIR Open Coil Suite consists of the following arrays available in 1.5T and 3.0T field strengths: - AIR Open Head Neck Posterior 9ch - AIR Open Neck Chest Anterior 7ch - AIR Open Head Anterior 16ch . The coils receive magnetic resonance signals generated in hydrogen nuclei (protons) in the Head, Neck and Brachial Plexus anatomy while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings. The received signals are amplified before being transferred to the MRI scanner through the coil's system cable. The amplified signals are processed by the MRI scanner into tomographic images of the Head, Neck and Brachial Plexus anatomy by the MRI scanner. Images are tvpically generated as axial, sagittal, coronal oblique slices. There are no accessories associated with the 32Ch AIR Open Coil Suite. Depending on the region of interest, the coils may be used in combination with the CIVCO RT Universal Couchtop™ MR Overlay for GE Motus, Kizuna, and GEM as well as the associated patient immobilization devices (e.g., thermoplastic mask, straps provided with the MRI scanner) The 1.5T 32Ch AIR Open Coil Suite and the 3.0T 32Ch AIR Open Coil Suite are tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla and 3.0 tesla magnetic field (respectively), which is governed by the Larmor equation. The 32Ch AIR Open Coil Suite is intended for use in a manner that is identical to the predicate device described in this submission. Proposed labeling is documented in the Instructions for Use manual for the 32Ch AIR Open Coil Suite (NC139IFU-en). Intended Use, including indications The 32Ch AIR Open Coil Suite are Magnetic Resonance Imaging (MRI) RF Receive-Only Coils intended to be used by trained medical professionals, for adult patients, in combination with and controlled by 1.5T or 3.0T GE Healthcare MRI system software. The 32Ch AIR Open Coil Suite is intended for use with specified couchtop and patient immobilization devices depending on the region of interest. When used as intended, the 32Ch AIR Open Coil Suite is used to produce diagnostic images of the head, neck, and brachial plexus structures. The images can be interpreted by medical professionals or facilitate Radiation Therapy (RT) planning. ### Technological Characteristics 32Ch AIR Open Coil Suite coils are similar in design, material, chemical composition and energy source to the legally marketed device, the 3.0T GEM RT Open Array, K143389 cleared on 03/06/2015. At a high level, the 1.5T 32Ch AIR Open Coil Suite and the 3.0T 32Ch AIR Open Coil Suite included as part of this submission, and the predicate device are based on the following same technological elements: - Prescription use; - Coil designs are receive-only phased array coils; ● - . Decoupling methodology: {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for NeoCoil. The logo consists of a black coil-like symbol on the left, followed by the word "NeoCoil" in blue and black. The "Neo" part of the word is in blue, while the "Coil" part is in black. - . Patient contacting materials and chemical composition are known materials that have been assessed for compliance with recognized biocompatibility standards; - Energy source for the coils is the MRI scanner; ● - No energy is supplied by the coils; ● - Coils designs are targeted for the head, neck and brachial plexus anatomy; ● - Mechanical designs are contoured for the head, neck and brachial plexus anatomy: ● - Facilitate Radiation Therapy (RT) planning; - Manufactured for use with the same MRI scanner manufacturer. The following technological differences exist between the subject and predicate device: - Optimized coil dimensions and geometry to support use on state-of-the-art MRI scanners ● and improve usability. - Field strength for the 1.5T 32Ch AIR Open Coil Suite . - . Channel count The Indications for Use for the 1.5T 32Ch AIR Open Coil Suite and 32Ch AIR Open Coil Suite are similar to the predicate device, the 3.0T GEM RT Open Array, K143389 cleared on 03/06/2015. Clinical and non-clinical testing demonstrates that the safety and/or effectiveness of the 32Ch AIR Open Coil Suites compared to the predicate device is not adversely affected as a result of the differences. ### Testing A combination of clinical and non-clinical performance data is included, referenced, or relied on to demonstrate that the 32Ch AIR Open Coil Suite is safe and effective and performs in a manner that demonstrates substantial equivalence to the predicate device, the 3.0T GEM RT Open Array, K143389 cleared on 03/06/2015. ### Performance testing - Bench: A Test Report Summary for non-clinical Bench Testing performed, including testing to FDArecognized consensus standards identified as relevant in FDA quidance document Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, issued November 18, 2016, is outlined below: | Test Performed | Objective(s) of the Test | Test Method Description | Pre-defined pass/fail criteria | Results Summary | Discussions / Conclusions | |------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------|----------------------------------------------------------------------------------------------------------------------------------------| | Biocompatibility Assessment | Assess potential biological risks | Evaluation of data; historical use, biologic testing, where warranted | Acceptable level of risk | Pass | No identified significant risks. | | Electrical Safety | Basic electrical safety/essential performance, 60601-1 | Test Lab | Pre-defined performance standards | Pass | Applicable requirements for basic electrical safety and essential performance met. | | Electrical Safety | Particular electrical requirements; MR equipment, 60601-2- 33 | Test Lab | Pre-defined performance standards | Pass | Applicable requirements of the particular standard were met. | | Test Performed | Objective(s) of the Test | Test Method Description | Pre-defined pass/fail criteria | Results Summary | Discussions / Conclusions | | Electrical Safety | Collateral electrical safety/essential performance, 60601- 1-2 | Test Lab / Bench Testing | Pre-defined performance standards | Pass | Applicable requirements of the collateral standard were met. | | Usability Assessment | Devices meet customer, end user and patient needs | Actual, simulated or retrospective evaluation of the device and/or data | Pre-defined requirements | Pass | The devices met the needs of the customer, end user and patient. | | Entrapment, Trapping Zone and Cable Looping (assessment w/ scanner) | Assess the device for pinch points, entrapment, cable looping - interfacing with MRI scanner | Evaluation of coil-to-scanner entrapment, trapping and cable looping not covered by test lab assessments. | Requirements based on pre- defined requirements in 60601-1 and customer requirements | Pass | Requirements were met. | | Surface Temperature | Surface temperatures do not exceed limits | MRI scanner test | Pre-defined performance standards | Pass | Surface temperatures were within IEC limits. | | Unplugged Surface Temperature | Devices remain safe in first fault condition | MRI scanner test | Acceptable level of risk | Pass | Surface temperatures were within IEC limits when the coil is left unplugged in the MRI scanner. | | Blocking Network Analysis | Ensures devices are designed with adequate active and passive transmit decoupling | Theoretical calculations | Adequate transmit decoupling | Pass | Blocking network demonstrates adequate active and passive transmit decoupling. | | Maximum B1 Peak | Demonstrate the devices can withstand the maximum B1 peak without obvious signs of arcing, burning, voltage breakdown | MRI scanner test and visual inspection | Pre-defined performance standards | Pass | Coils were able to withstand maximum B1 peak without obvious signs of arcing, burning or voltage breakdown. | | B1 Field Distortion | Measure amount of distortion produced due to presence of an RF coil in the scanner | MRI scanner test | Pre-defined performance standards | Pass | B1 field inhomogeneity meets performance requirements and demonstrates adequate active and passive transmit decoupling. | | B0 Filed Distortion | Measure amount of distortion produced due to presence of an RF coil in the scanner | MRI scanner test | Pre-defined performance standards | Pass | B0 field inhomogeneity meets performance requirements and demonstrates adequate active and passive transmit decoupling. | | Test Performed | Objective(s) of the Test | Test Method Description | Pre-defined pass/fail criteria | Results Summary | Discussions Conclusions | | NEMA MS 6- 2008 | Evaluate single- channel non-volume special purpose radiofrequency (RF) coils for use with magnetic resonance (MR) imaging (MRI) systems | MRI scanner test | Pre-defined performance standards | Pass | SNR and Image Uniformity are consistent with the requirements for indications for use. | {6}------------------------------------------------ N27 W23910A Paul Rd Pewaukee, WI 53072 USA Direct: (262) 347-1250 Fax: (262) 347-1251 Image /page/6/Picture/1 description: The image shows the logo for NeoCoil. The logo consists of a black circular shape on the left and the word "NeoCoil" in blue on the right. The circular shape appears to be a stylized representation of a coil or spiral. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image contains the logo for NeoCoil. The logo consists of a black circular shape with an arrow pointing to the right, followed by the word "NeoCoil" in blue. The wordmark is in a sans-serif font and is slightly larger than the circular shape. ### Performance testing - Clinical: Clinical data exhibits a mix of technical factors and anatomy as recommended in FDA guidance; Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices issued November 18, 2016. No adverse events were reported during clinical performance testing. Image /page/7/Picture/6 description: The image shows a comparison of MRI scans taken with 1.5T and 3.0T 32Ch AIR Open Coil Suites. The top row displays coronal T2-weighted images without fat saturation, while the bottom row shows sagittal T2-weighted images, also without fat saturation. The left column shows images from the 1.5T suite, and the right column shows images from the 3.0T suite, allowing for a direct visual comparison of image quality and detail between the two different MRI systems. {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for NeoCoil. The logo consists of a black coil-like symbol on the left and the word "NeoCoil" in blue on the right. The coil symbol has an arrow pointing to the right, suggesting movement or flow. Image /page/8/Figure/2 description: The image shows a comparison of MRI scans taken with 1.5T and 3.0T 32Ch AIR Open Coil Suites. The top row displays axial T2-weighted images of the brain without fat saturation, while the bottom row shows axial T2-weighted images of the neck without fat saturation. The left column shows images taken with the 1.5T coil, and the right column shows images taken with the 3.0T coil. The images show the differences in image quality and resolution between the two coil suites. ### Conclusion This submission demonstrates by means of nonclinical and clinical testing that the 32Ch AIR Coil Suite are safe and effective and perform as well as or better than the predicate device, the 3.0T GEM RT Open Array, K143389 cleared on 03/06/2015 for the indications claimed.