32Ch AIR Open Coil Suite, 1.5T

EUDAMEDFDA UDIFDA 510(k)

Class I (EU MDR)

Ref NC139021Model 32Ch AIR Open Coil

by NeoCoil, LLC

Identity

Trade Name: 32Ch AIR Open Coil Suite, 1.5T EUDAMEDFDA UDI
Generic Name: MRI system coil, radio-frequency FDA UDI
Device Name: 32Ch AIR Open Coil EUDAMED
The 32Ch AIR Open Coil Suite,1.5T (NeoCoil Ref#: NC139021; GEHC Ref#: M7025RT) 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) scanners. The 32Ch AIR Open Coil Suite consists of the following arrays available in 1.5T 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 typically 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™ MRI Overlay for compatible MR table(s) and associated patient immobilization devices (e.g., thermoplastic mask, straps provided with the MRI scanner). FDA UDI
Model / Reference: 32Ch AIR Open Coil EUDAMED
NC139021 EUDAMED
50 FDA UDI
Description: The 32Ch AIR Open Coil Suite,1.5T (NeoCoil Ref#: NC139021; GEHC Ref#: M7025RT) 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) scanners. The 32Ch AIR Open Coil Suite consists of the following arrays available in 1.5T 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 typically 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™ MRI Overlay for compatible MR table(s) and associated patient immobilization devices (e.g., thermoplastic mask, straps provided with the MRI scanner). FDA UDI

Identifiers

Catalog Number: NC139021 FDA UDI
Primary DI / UDI-DI: 00850028932506 EUDAMEDFDA UDI
Basic UDI-DI: 0850028932437K EUDAMED
510(k) Number: K213687 FDA UDI
FDA Product Code: MOS FDA UDI
EMDN Code: Z1105018001 MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS EUDAMED
GMDN Term: MRI system coil, radio-frequency FDA UDI

Classification

Device Class: Class I EUDAMED
Class II FDA UDI
Regulation Number: 892.1000 FDA UDI
Market of Registration: Netherlands EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: MRI system coil, radio-frequency

32Ch AIR Open Coil Suite, 1.5T by Neocoil, Llc — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

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Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K213687	Class I	Active
EUDAMED	European Union	CE/MDR	0850028932437K	Class I	Active

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Manufacturer

Manufacturer: NeoCoil, LLC
EUDAMED SRN: US-MF-000027128
Authorised Representative: Emergo Europe B.V. NL-AR-000000116

Sources (3)

EUDAMED 51b41f70-cc18-4739-b691-29d81e6b4ac8 61 fields · synced Jun 18, 2026
FDA UDI 6714a462-f503-4154-b85e-80b555e2ac9c 36 fields · synced May 30, 2026
FDA 510(k) K213687 1 fields · synced May 18, 2026