DuoFLEX® Coil Suite

FDA UDI

Class II (US FDA UDI)

by Mr Instruments, Inc.

Identity

Trade Name: DuoFLEX® Coil Suite FDA UDI
Generic Name: MRI system coil, radio-frequency FDA UDI
Device Name: The 10cm Left Coil Assembly is a part of the DuoFLEX® Coil Suite. The MR Instruments FC 1500S-8R DuoFLEX® Coil Suite includes two different sets of coil paddles and a single, shared preamplifier box with a system connector. The first coil set consists of two 24cm foam paddles containing four loops/channels per paddle for a total of eight channels for the two paddles. The second coil set consists of two 10cm square foam paddles containing four loops/channels per paddle for a total of eight channels for the two paddles. All of these paddles connect to the same preamplifier box containing eight preamplifiers; only one pair can be connected at a time. The coil design for all of the paddles has the same, simple antennae design and the same system connectivity configuration. The coils can be used in several configurations, including any single coil and any two coils, providing 4 or 8 channels for imaging. FDA UDI
Model / Reference: FC1500S-8R FDA UDI
Description: The 10cm Left Coil Assembly is a part of the DuoFLEX® Coil Suite. The MR Instruments FC 1500S-8R DuoFLEX® Coil Suite includes two different sets of coil paddles and a single, shared preamplifier box with a system connector. The first coil set consists of two 24cm foam paddles containing four loops/channels per paddle for a total of eight channels for the two paddles. The second coil set consists of two 10cm square foam paddles containing four loops/channels per paddle for a total of eight channels for the two paddles. All of these paddles connect to the same preamplifier box containing eight preamplifiers; only one pair can be connected at a time. The coil design for all of the paddles has the same, simple antennae design and the same system connectivity configuration. The coils can be used in several configurations, including any single coil and any two coils, providing 4 or 8 channels for imaging. FDA UDI

Identifiers

Catalog Number: 40-00298-001 FDA UDI
Primary DI / UDI-DI: 00857371006212 FDA UDI
510(k) Number: K173290 FDA UDI
FDA Product Code: MOS FDA UDI
GMDN Term: MRI system coil, radio-frequency FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1000 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: MRI system coil, radio-frequency

DuoFLEX® Coil Suite by Mr Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as MRI system coil, radio-frequency.

Dunlee Sentinelle — Philips Medical Systems Nederland B.V. · Class II
All-Purpose Arch — NORAS MRI products GmbH · Class II
LEYLA Retractor Socket — NORAS MRI products GmbH · Class II
16Ch Flex SPEEDER Pad Kit — NEOCOIL, LLC · Class II
All-Purpose Arch Adapter — NORAS MRI products GmbH · Class II
Operator's Manual Flexibility Siemens — NORAS MRI products GmbH · Class II
NORAS OR HEADCOIL Bottom Array Siemens 3T Refurbished — NORAS MRI products GmbH · Class II
ScanMed Long Bone (L) Coil — SCANMED, LLC · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Mr Instruments, Inc.

Sources (1)

FDA UDI 2ea454ac-6995-4b6f-84d6-fe4c439fde27 35 fields · synced May 30, 2026