FDA.reportPublic FDA data

special purpose coil 4

Primary DI
04056869015330
Brand
special purpose coil 4
Company
Siemens Shenzhen Magnetic Resonance Ltd.
Model
10654891
Device description
MRI Coil
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LNHSystem, nuclear magnetic resonance imaging
LNISystem, nuclear magnetic resonance spectroscopic
MOSCoil, magnetic resonance, specialty
OUOTomographic imager combining emission computed tomography with nuclear magnetic resonance

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2
LNISystem, Nuclear Magnetic Resonance SpectroscopicRadiology2
MOSCoil, Magnetic Resonance, SpecialtyRadiology2
OUOTomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic ResonanceRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056869015330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056869015330040568690153304056869015330

GMDN Terms#

Term, Definition table
TermDefinition
PET/MRI systemA diagnostic radiological imaging system that is a combination of a positron emission tomography (PET) camera system for nuclear medicine (NM) images, and a magnetic resonance imaging (MRI) system for magnetic resonance images. The nuclear medicine images and the magnetic resonance images may be registered and displayed in a fused format (overlaid in the same orientation) for the anatomical localization of the nuclear medicine data (i.e., distribution of radiopharmaceuticals). The PET and MRI portions of the system may be used independently or in combination; their images may be transferred to other systems for additional processing.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)888-7436XX@XX.XX
+1(800)888-7436CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
544891302
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056869997926MAGNETOM Flow.Plus115713122025-07-07
04056869997933MAGNETOM Flow.Plus115713132025-07-07
04056869281759MAGNETOM Free.Max114084242022-09-01
04056869281766MAGNETOM Free.Star114084262022-09-01
04056869281773MAGNETOM Free.Star114084272022-09-01
04056869281742MAGNETOM Free.Max114084252021-08-02
04056869996202MAGNETOM Flow.Ace115712472025-07-07
04056869996219MAGNETOM Flow.Ace115712482025-07-07
04056869281926Contour M Coil Set114076772022-09-01
04056869281858Head/Neck Coil114076592021-08-02
04056869281896Head/Neck Coil Set114076602021-08-02
04056869281933Spine Coil114073782021-08-02
04056869281940Spine Coil Set114073772021-08-02
04056869163383Shoulder Shape 16112928052021-07-30
04056869165325Shoulder Shape 16 Coil Set 1.5T112928062021-07-30
04056869231105Flex large 8112931342021-07-30
04056869231112Flex Large 8 Coil Set 1.5T112931332021-07-30
04056869231129BM Body 13114072552021-07-30
04056869231136BM Body 13 MR Coil Set 1.5T114072562021-07-30
04056869231167Flex Small 8 Coil Set 1.5T112931352021-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04573596201367OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201398OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201404OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201411OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201435OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596202159OASISFUJIFILM CORPORATIONLNH2026-05-29
04260486610339NBAC 3.0T PH I FlexLMT Medical Systems GmbHMOS2026-04-28
04260486610605NBAC 1.5T GE P SpineLMT Medical Systems GmbHMOS2026-04-28
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.LNH2026-04-23
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.LNH2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162854Mask DSPS®-PROSCVRL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162861Mask DSPS®-PROSC set/5MACROMEDICS B.V.LNH2026-04-22
08720168162878Mask DSPS®-PROSCVR set/5MACROMEDICS B.V.LNH2026-04-22
08720168162885Mask DSPS®-PROSCL set/5MACROMEDICS B.V.LNH2026-04-22
08720168163356DSPS-Prominent® SH profile set/2MACROMEDICS B.V.LNH2026-04-22
08720168163387DSPS PRO Mask Shim Set HNSMACROMEDICS B.V.LNH2026-04-22
08720168163394DSPS PRO Mask Shim Set HOMACROMEDICS B.V.LNH2026-04-22
10841439114732PronumbraMEDTEC, INC.LNH2025-09-12
10841439114749PronumbraMEDTEC, INC.LNH2025-09-12
10841439114770PronumbraMEDTEC, INC.LNH2025-09-12
10841439114787PronumbraMEDTEC, INC.LNH2025-09-12
08056304455727G-scan OpenESAOTE SPALNH2024-07-02
04260486610483NHAC 1.5T PH I 16LMT Medical Systems GmbHMOS2024-04-23
04260486610537NHAC 3.0T PH I 16LMT Medical Systems GmbHMOS2024-04-23
04260486610582NBAC 1.5T PH I SpineLMT Medical Systems GmbHMOS2024-04-23
04260486610599NBAC 3.0T PH I SpineLMT Medical Systems GmbHMOS2024-04-23