FDA.reportPublic FDA data

Somatom Perspective

Primary DI
04056869010335
Brand
Somatom Perspective
Company
Siemens Shanghai Medical Equipment Ltd.
Model
10495568
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
JAKSystem, x-ray, tomography, computed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113287000
K133590000
K151765000
K183548000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113287000SOMATOM PERSPECTIVESiemens Medical Solutions USA, Inc.2012-05-23JAK
K133590000SOMATOM PERSPECTIVESiemens Medical Solutions USA, Inc.2014-04-30JAK
K151765000SOMATOM PerspectiveSiemens Medical Solutions USA, Inc.2016-03-25JAK
K183548000SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16Siemens Medical Solutions USA, Inc.2019-04-15JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056869010335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056869010335040568690103354056869010335

GMDN Terms#

Term, Definition table
TermDefinition
Full-body CT systemAn assembly of diagnostic x-ray computed tomography (CT) devices with a gantry large enough to allow imaging of any part of the body. It includes designs with single or multiple fixed annular arrays of x-ray tubes and opposing detectors or those with x-ray tube(s) and opposing detector assemblies that rotate rapidly around a central axis point within the gantry imaging area. It can produce two and/or three-dimensional (3-D) cross-sectional (tomographic) images, including spiral CT or other special imaging applications at multiple specified angles in relation to body position. It may use a variety of digital techniques for information capture, image reconstruction, and display.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius50 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

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
654129626
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056869951386MULTIX Impact E11333999113339992022-09-26
04056869279985MULTIX Impact11333888113338882021-04-20
04056869262147MULTIX Impact C11020896110208962021-03-22
04056869010304SOMATOM Emotion 16-slice configuration101659772016-09-24
04056869010311SOMATOM Scope109676662016-09-24
04056869010342Somatom Perspective SSME108916662016-09-24
04056869295541SOMATOM X.cite115012002025-11-30
04056869295558SOMATOM X.ceed115012012025-11-30
04056869973500SOMATOM Pro.Pulse115947882025-11-30
04056869239736SOMATOM go.Sim110616682020-09-25
04056869239743SOMATOM go.Open Pro110616782020-08-29
04056869051307SOMATOM go.Now110616182017-04-06
04056869051321SOMATOM go.Up110616282017-04-06
04056869151588SOMATOM go.All110616382018-05-26
04056869151595SOMATOM go.Top110616482018-05-26
04056869267180CIOS SELECT115150882023-06-08
04056869267197CIOS SELECT115150552023-06-07
04056869226545MULTIX Impact110207882020-09-23
04056869019888Multix Fusion VA10107466652016-09-24
04056869019895Multix Fusion VA30107466672016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-06-05
10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.JAK2026-06-02
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.JAK2026-05-27
00850025268424Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-05-12
00850025268400Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-02-27
00850025268394Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-01-21
00850025268387Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-11-03
00850025268370Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-09-24
00850025268349Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-07-11
00850025268363Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-06-03
00850025268356Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-05-23
00850025268332Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-05-16
08800025300299AVIEWCORELINE SOFT CO.,LTD.JAK2025-03-27
08800025300367AVIEW CACCORELINE SOFT CO.,LTD.JAK2025-03-24
00850025268318Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-03-21
00850025268325Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-11-21
00850025268301Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-09-20
00850025268257Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-09-05
00850025268295Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-08-13
10884521837102ILLUMISITECovidien LPJAK2024-08-09
10884521837126ILLUMISITECovidien LPJAK2024-08-09
10884521837133ILLUMISITECovidien LPJAK2024-08-09
10884521837140ILLUMISITECovidien LPJAK2024-08-09
10884521837157ILLUMISITECovidien LPJAK2024-08-09
10884521842915ILLUMISITECovidien LPJAK2024-08-09
07640167220021CAS-One IR Consumable Set GeneralCAScination AGJAK2024-06-17
00850025268240Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-05-02
08800025300237AVIEW CACCORELINE SOFT CO.,LTD.JAK2024-04-25
00850025268233Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-04-12
00850025268226Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-01-29