FDA.reportPublic FDA data

DxTx Medical 1.5T Imaging Device (for Siemens)

Primary DI
00850011472200
Brand
DxTx Medical 1.5T Imaging Device (for Siemens)
Company
DXTX MEDICAL INC
Model
FID SYM
Device description
Ecoil ID - FID SYM
Published
2020-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Product Codes#

Code, Name table
CodeName
LNHSystem, Nuclear Magnetic Resonance Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K971380000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971380000MEDRAD FLEX INTERFACE DEVICEMedrad, Inc.1997-07-03LNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850011472200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011472200008500114722008500114722000850011472200

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.

Regulatory Flags#

DUNS number
082448484
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850011472170Endorectal MRI Coil for 3.0T MR Imaging of the Prostate (eCoil®)BPX 30BPX 302019-12-11
008500114720191.5T Ingenia Endorectal Coil Interface Device (eCoil®)4598-001-138024598-001-138022020-06-08
008500114720881.5T Ingenia Endorectal Coil Interface Device System (eCoil®)9896-030-191229896-030-191222020-06-08
008500114720953.0T Ingenia Endorectal Coil Interface Device (eCoil®)4598-001-138124598-001-138122020-06-08
008500114721013.0T Ingenia Endorectal Coil Interface Device System (eCoil®)9896-030-190329896-030-190322020-06-08
00850011472149Endorectal MRI Coil for 1.5T MR Imaging of the Prostate (eCoil®)BPX 15BPX 152019-12-11
00850011472224DxTx Medical 1.5T eCoil Imaging Device (for GE)M64ERA8-P2021-04-05
00850011472026DxTx Medical 1.5T eCoil Imaging Device FRU (for Philips Ingenia)4598-001-138012020-06-08
00850011472033DxTx Medical 1.5T eCoil Imaging Device FRU (for Philips Ingenia)4598-001-138012020-06-08
00850011472040DxTx Medical 3T eCoil Imaging Device (for Philips)9896-030-190312020-06-08
00850011472057DxTx Medical 1.5 T eCoil Imaging System (For Philips)9896-030-191212020-06-08
00850011472064DxTx Medical 3T eCoil Imaging Device (for GE)M128ERA8-HD2020-06-08
00850011472071DxTx Medical 1.5T eCoil Imaging Device (for GE)M64ERA8-HD2020-06-08
00850011472132DxTx Medical 1.5T eCoil Imaging System Disposables (Cervix)BCR 152020-06-08
00850011472156DxTx Medical 1.5T eCoil Imaging System Disposables (Colon)PCC 152020-06-08
00850011472187DxTx Medical 3T eCoil Imaging Device (FRU for Siemens)STID TIM 30 FRU2020-06-08
00850011472194DxTx Medical 3T eCoil Imaging Device (for Siemens)STID TIM 302020-06-08
00850011472217DxTx Medical 1.5T eCoil Imaging Device (for Siemens)FID SYM FRU2020-06-08
00850011472118DxTx Medical 3T eCoil Imaging System Disposables (Prostate - Philips)4522-132-647512019-12-11
00850011472125DxTx Medical 1.5T eCoil Imaging System Disposables (Prostate - Philips)4522-132-706812019-12-11

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