FDA.report

3T PA matrix MR coil

Primary DI
04056869014333
Brand
3T PA matrix MR coil
Company
Siemens Healthcare GmbH
Model
08622750
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
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LNHSystem, nuclear magnetic resonance imaging

Product Code Classifications

CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04056869014333PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04056869014333040568690143334056869014333

GMDN Terms

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

Contacts

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

Regulatory Flags

DUNS number
313217003
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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