FDA.reportPublic FDA data

32Ch Head Coil

Primary DI
00857371006007
Brand
32Ch Head Coil
Company
M R Instruments, Inc.
Model
MC 3003G-32R
Device description
The MC 3003G-32R is a multi-channel receive only RF head coil. It has 32 RF elements that are tuned to 1H at 3T (127.8 MHz). Each element has active and passive blocking networks and integrated preamplifiers. The housing is constructed out of a rigid plastic with an opening for patient viewing and comfort. A head support/base is included.
Published
2016-06-21
Public version status
Update
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
K072931000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072931000MC 3003G-32R HEAD COILMr Instruments, Inc.2007-10-30MOS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857371006007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857371006007008573710060078573710060070857371006007

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
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00857371006175DuoFLEX® Coil SuiteFC3000G-8R40-00190-0022022-03-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195278925282NAGE HEALTHCARE(TIANJIN) COMPANY LIMITEDMOS2026-05-11
00814848020836Contour Hand Wrist 0.55TQUALITY ELECTRODYNAMICS LLCMOS2026-04-23
00850083516000Nuzzle Body Array, 1.5TInkspace Imaging, Inc.MOS2026-04-21
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
00884838130548DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130555DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
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00884838111172DUNLEEPhilips Medical Systems Nederland B.V.MOS2025-09-30
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