FDA.report

NA

Primary DI
B318PACCGS151
Brand
NA
Company
Machnet B.V.
Model
PACC-GS15
Catalog number
PACC-GS15
Device description
Bilateral Four Channel Phased Array CAROTIDS COIL for bilateral MRI proton imaging of the carotids bifurcation. The Carotids Coil enables sub-millimeter resolution of the carotids lumen, vessel walls and atherosclerotic plaques. Compatible with GE Signa 1.5T scanners.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
MOSCoil, Magnetic Resonance, Specialty

Product Code Classifications

CodeDeviceSpecialtyClass
MOSCoil, Magnetic Resonance, SpecialtyRadiology2

Premarket Submissions

SubmissionSupplement
K012491000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K012491000MACHNET CAROTIDS COIL ARRAY ASSEMBLYMachnet BV2001-10-24MOS

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B318PACCGS151PrimaryHIBCC0

GMDN Terms

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

Contacts

PhoneEmail
+31505779846info@machnet.nl

Regulatory Flags

DUNS number
416060564
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B318PACCGD15501NAPACC-GD15-50PACC-GD15-502016-09-23
B318PACCGD30501NAPACC-GD30-50PACC-GD30-502016-09-23
B318PACCGS15HDX1NAPACC-GS15-HDxPACC-GS15-HDx2016-09-23
B318PACCGS30HDX1NAPACC-GS30-HDxPACC-GS30-HDx2016-09-23
B318PACCSS151NAPACC-SS15PACC-SS152016-09-23
B318PACCST301NAPACC-ST30PACC-ST302016-09-23

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