FDA.reportPublic FDA data

1.5T Endorectal Coil

Primary DI
04260487680232
Brand
1.5T Endorectal Coil
Company
RAPID Biomedical GmbH
Model
O-HLE-015-01899
Catalog number
M7006CL
Device description
1.5T Endorectal Coil (P-Port)
Published
2020-03-09
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
K191539000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1915390001.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil SupportRapid Biomedical GmbH2020-01-31MOS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260487680232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260487680232042604876802324260487680232

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal107 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius24 Degrees Celsius
Handling Environment Temperature59 Degrees Fahrenheit75.2 Degrees Fahrenheit
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-13 Degrees Fahrenheit140 Degrees Fahrenheit

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
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
0426048768081213C/1H Head Coil020142023-02-13

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