FDA.report

Symbia_Intevo_Bold

Primary DI
04056869044798
Brand
Symbia_Intevo_Bold
Company
SIEMENS MEDICAL SOLUTIONS USA, INC.
Model
11007962
Published
2017-03-27
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
KPSSystem, tomography, computed, emission

Product Code Classifications

CodeDeviceSpecialtyClass
KPSSystem, Tomography, Computed, EmissionRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04056869044798PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04056869044798040568690447984056869044798

GMDN Terms

TermDefinition
SPECT/CT systemAn assembly of diagnostic devices that comprise a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine (NM) images, and a computed tomography (CT) camera system for x-ray images. The nuclear medicine images and the x-ray 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 SPECT and CT portions of the system may be used independently or in combination and the images may be transferred to other systems for radiation therapy planning or additional processing.

Storage And Handling

TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius49 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius49 Degrees Celsius

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
868230876
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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04068151027013MI View&GOVA32024-09-06
04068151012477ACUSON Origin ICE Diagnostic Ultrasound System116694002024-08-22
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040568699507476C1 HD Transducer116572232024-05-08
0405686995075418L6HD Transducer116572242024-05-08
0405686995424018L6 Transducer116573842024-05-08
0405686995425718L6 Transducer116573852024-05-08
0405686995435614L5 Transducer116573872024-05-08

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00859873006240HermiaHermes Medical Solutions ABKPS2026-03-05
B133NEUROQ412601160NeuroQSYNTERMED INCORPORATEDKPS2026-03-04
B133ECTB422512090Cardiac ToolboxSYNTERMED INCORPORATEDKPS2026-02-26
07290108670523D-SPECT RefurbishedSPECTRUM DYNAMICS MEDICAL, INCKPS2026-02-09
04068151048070Biograph Trinion.X EP9 CT64SIEMENS MEDICAL SOLUTIONS USA, INC.KPS2026-01-09
08809873532005BRIGHTONIXBrightonix Imaging Inc.KPS2025-09-23
08809873532012BRIGHTONIXBrightonix Imaging Inc.KPS2025-09-23
08809873532029BRIGHTONIXBrightonix Imaging Inc.KPS2025-09-23
08809873532036BRIGHTONIXBrightonix Imaging Inc.KPS2025-09-23
08809873532043BRIGHTONIXBrightonix Imaging Inc.KPS2025-09-23
08809873532050BRIGHTONIXBrightonix Imaging Inc.KPS2025-09-23
04068151048063Biograph Trinion.X EP9 CT128SIEMENS MEDICAL SOLUTIONS USA, INC.KPS2025-08-28
B133NEUROQ412507140NeuroQSYNTERMED INCORPORATEDKPS2025-08-06
06971576832163uMIShanghai United Imaging Healthcare Co., Ltd.KPS2025-08-03
06971576832231uMIShanghai United Imaging Healthcare Co., Ltd.KPS2025-08-03
06971576832255uMIShanghai United Imaging Healthcare Co., Ltd.KPS2025-08-03
B133ECTB4225063000Emory Cardiac ToolboxSYNTERMED INCORPORATEDKPS2025-08-01
30815112021543HeartSee Cardiac PET Processing SoftwareBracco Diagnostics Inc.KPS2025-07-25
07290108670097D-SPECT RefurbishedSPECTRUM DYNAMICS MEDICAL, INCKPS2025-06-30
B133NEUROQ402505160NeuroQSYNTERMED INCORPORATEDKPS2025-06-18
04540217072798PositViewSHIMADZU CORPORATIONKPS2025-05-16
B133ECTB422503240Emory Cardiac ToolboxSYNTERMED INCORPORATEDKPS2025-03-26
B133NEUROQ402503120NeuroQSYNTERMED INCORPORATEDKPS2025-03-21
06430070844015cNeuro cPETCombinostics OyKPS2025-02-24
00850031455016RADIALIS PET CAMERARadialis IncKPS2025-02-07
B133NEUROQ40241250NeuroQSYNTERMED INCORPORATEDKPS2025-01-27
00859873006189HermiaHermes Medical Solutions ABKPS2024-12-10
04540217071630SET-5002SHIMADZU CORPORATIONKPS2024-12-04
08437018413188CAREMIBRAINGENERAL EQUIPMENT FOR MEDICAL IMAGING SAKPS2024-05-28
00195278870490StarGuide MDD to MDR UpgradeG E MEDICAL SYSTEMS ISRAEL LTD.KPS2024-05-16