FDA.reportPublic FDA data

23Na 1Tx32Rx Head Coil Set 7T

Primary DI
04260487680324
Brand
23Na 1Tx32Rx Head Coil Set 7T
Company
RAPID Biomedical GmbH
Model
11371302
Device description
23Na 1Tx32Rx Head Coil Set 7T
Published
2019-08-23
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
K183222000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183222000MAGNETOM TerraSiemens Medical Solutions USA, Inc.2019-02-15LNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260487680324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260487680324042604876803244260487680324

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal107 KiloPascal
Handling Environment Humidity15 Degrees Celsius24 Degrees Celsius
Handling Environment Humidity30 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
316037741
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
042604876802321.5T Endorectal CoilO-HLE-015-01899M7006CL2020-03-09
042604876802493.0T Endorectal CoilO-HLE-030-01900M7006CM2020-03-09
042604876804161.5T Endorectal CoilO-HLE-015-01946M7006CQ2020-03-09
04260487680423Endorectal Coil SupportZUB-01955M7006CY2020-03-09
04260487680430Endorectal Coil Screws Repair KitZUB-01978none2020-03-09
04260487680447Endorectal Coil Holder Repair KitZUB-01979none2020-03-09
0426048768057731P/1H Head Coil020002023-02-13
0426048768058423Na/1H Head Coil020012023-02-13
0426048768059113C/1H Head Coil020022023-02-13
0426048768060731P/1H Head Coil020032023-02-13
0426048768061423Na/1H Head Coil020042023-02-13
0426048768062113C/1H Head Coil020052023-02-13
0426048768063831P/1H Head Coil020062023-02-13
0426048768064523Na/1H Head Coil020072023-02-13
0426048768065213C/1H Head Coil020082023-02-13
0426048768069031P/1H Head Coil021042023-02-13
0426048768070613C/1H Head Coil021052023-02-13
0426048768078223Na/1H Head Coil020182023-02-13
0426048768079931P/1H Head Coil020122023-02-13
0426048768080523Na/1H Head Coil020132023-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
001989531114373.0T AIR 32CH HNAUSA INSTRUMENTS, INC.MOS2026-11-02
00850042098172MRI Receive Coil (Receive Only)Promaxo LLCMOS2026-10-19
00850042098196Fiducial CoilPromaxo LLCMOS2026-10-19
00198953007716NAGE Medical Systems, L.L.C.MOS2026-10-07
001989530665533.0T AIR PA XLUSA INSTRUMENTS, INC.MOS2026-10-07
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