GEM Flex Coil 16-M Array, 1.5T Receive Only

EUDAMEDFDA UDIFDA 510(k)

Class I (EU MDR)

Ref NC023200Model GEM Flex Coil510(k) K113474

by NeoCoil, LLC

Identity

Trade Name: GEM Flex Coil 16-M Array, 1.5T Receive Only EUDAMED
1.5T GEM Flex Coil 16-M Array FDA UDI
Generic Name: MRI system coil, radio-frequency FDA UDI
Device Name: GEM Flex Coil EUDAMED
The NeoCoil 1 .5T GEM Flex Coil is a receive-only phased array coil system for imaging the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine in pediatric and adult populations. The NecCoil 1 .5T GEM Flex Coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation. FDA UDI
Model / Reference: GEM Flex Coil EUDAMED
NC023200 EUDAMED
08 FDA UDI
Description: The NeoCoil 1 .5T GEM Flex Coil is a receive-only phased array coil system for imaging the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine in pediatric and adult populations. The NecCoil 1 .5T GEM Flex Coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation. FDA UDI

Identifiers

Primary DI / UDI-DI: 00856181003084 EUDAMEDFDA UDI
Basic UDI-DI: 0850028932407D EUDAMED
Direct Marketing DI: 00856181003084 EUDAMED
510(k) Number: K113474 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

Yes

FDA UDI

Category: MRI system coil, radio-frequency

GEM Flex Coil 16-M Array, 1.5T Receive Only 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	K113474	Class I	Active
EUDAMED	European Union	CE/MDR	0850028932407D	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 4ab182a5-fa6d-4fe5-8f08-fd26378d718d 85 fields · synced Jun 18, 2026
FDA UDI 4fb4b647-3e36-476d-a35b-456558c41572 34 fields · synced May 30, 2026
FDA 510(k) K113474 1 fields · synced May 18, 2026