FDA.reportPublic FDA data

DxTx Medical 1.5T eCoil Imaging Device (for GE)

Primary DI
00850011472224
Brand
DxTx Medical 1.5T eCoil Imaging Device (for GE)
Company
DXTX MEDICAL INC
Model
M64ERA8-P
Device description
Ecoil ID - 1.5T GE - M64ERA8-P
Published
2021-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
K053042000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053042000MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICEMedrad, Inc.2005-11-17MOS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850011472224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011472224008500114722248500114722240850011472224

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
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
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
00850011472200DxTx Medical 1.5T Imaging Device (for Siemens)FID SYM2020-06-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838111622Smart Fit Shoulder 1.5TPhilips Healthcare (Suzhou) Co., Ltd.MOS2026-06-26
00884838112667Smart Fit Knee 3.0TPhilips Healthcare (Suzhou) Co., Ltd.MOS2026-06-26
00884838131866Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) Co., Ltd.MOS2026-06-26
00884838133235dS MSK M 1.5TPhilips Healthcare (Suzhou) Co., Ltd.MOS2026-06-26
00884838133242dS MSK S 1.5TPhilips Healthcare (Suzhou) Co., Ltd.MOS2026-06-26
00195278925282NAGE HEALTHCARE(TIANJIN) COMPANY LIMITEDMOS2026-05-11
04260486610339NBAC 3.0T PH I FlexLMT Medical Systems GmbHMOS2026-04-28
04260486610605NBAC 1.5T GE P SpineLMT Medical Systems GmbHMOS2026-04-28
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
00884838130562DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130579DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130586DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130593DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130609DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130616DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130623DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838132597DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838132603DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838093089MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838093096MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838093102MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838098190MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838098367MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838098510MRI CoilsPhilips Ds North America LLCMOS2025-10-01