FDA.reportPublic FDA data

DuoFLEX® Coil Suite

Primary DI
00857371006175
Brand
DuoFLEX® Coil Suite
Company
M R Instruments, Inc.
Model
FC3000G-8R
Catalog number
40-00190-002
Device description
The 24cm Right Coil Assembly is a part of the DuoFLEX® Coil Suite. The MR Instruments FC 3000G-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.
Published
2022-03-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MOSCoil, Magnetic Resonance, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOSCoil, Magnetic Resonance, SpecialtyRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173290000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173290000DuoFLEX Coil SuiteMr Instruments, Inc.2017-11-28MOS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857371006175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857371006175008573710061758573710061750857371006175

GMDN Terms#

Term, Definition table
TermDefinition
MRI system coil, radio-frequencyA radio-frequency (RF) coil acts as a transmitter, receiver, or both a transmitter and receiver of RF pulses necessary for diagnostic magnetic resonance imaging (MRI) procedures. It is used to enhance image resolution by improving signal to noise characteristics. There are two main kinds of RF coils: volume coils (which surround the part of the body being imaged) and surface coils (which are placed and secured directly on or under an area of interest). This group of devices includes a variety RF coil designs and configurations including, e.g., surface coils, phased array coils, paired saddle coils, Hemholtz pair coils or bird cage coils.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
112719096
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
0085737100600732Ch Head CoilMC 3003G-32R2016-06-21
008573710060141.5T DuoFLEX Standard SuiteFC 1500G-8R2016-07-25
00857371006137DuoFLEX® Coil SuiteFC3000G-8R40-00192-0042022-03-10
00857371006144DuoFLEX® Coil SuiteFC3000G-8R40-00188-0012022-03-10
00857371006151DuoFLEX® Coil SuiteFC3000G-8R40-00188-0022022-03-10
00857371006168DuoFLEX® Coil SuiteFC3000G-8R40-00190-0012022-03-10
00857371006205DuoFLEX® Coil SuiteFC1500S-8R40-00192-0062022-03-10
00857371006212DuoFLEX® Coil SuiteFC1500S-8R40-00298-0012022-03-10
00857371006229DuoFLEX® Coil SuiteFC1500S-8R40-00298-0022022-03-10
00857371006236DuoFLEX® Coil SuiteFC1500S-8R40-00295-0012022-03-10
00857371006243DuoFLEX® Coil SuiteFC1500S-8R40-00295-0022022-03-10
00857371006274DuoFLEX® Coil SuiteFC3000S-8R40-00192-0072022-03-10
00857371006281DuoFLEX® Coil SuiteFC3000S-8R40-00280-0012022-03-10
00857371006298DuoFLEX® Coil SuiteFC3000S-8R40-00280-0022022-03-10
00857371006304DuoFLEX® Coil SuiteFC3000S-8R40-00281-0012022-03-10
00857371006311DuoFLEX® Coil SuiteFC3000S-8R40-00281-0022022-03-10
00857371006342DuoFLEX® Coil SuiteFC1520G-8R40-00192-0052022-03-10
00857371006359DuoFLEX® Coil SuiteFC1520G-8R40-00300-0012022-03-10
00857371006366DuoFLEX® Coil SuiteFC1520G-8R40-00300-0022022-03-10
00857371006373DuoFLEX® Coil SuiteFC1520G-8R40-00297-0012022-03-10

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Primary DI, Brand, Company table
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00850083516017Silhouette Body Array – PH 3T (Cherry Blossoms)Inkspace Imaging, Inc.MOS2026-04-21
00860008041371Snuggle Pediatric Array – PH 3T (Dino)Inkspace Imaging, Inc.MOS2026-04-21
00860008041395Nuzzle Body Array – PH 3T (Whimsical)Inkspace Imaging, Inc.MOS2026-04-21
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