FDA.reportPublic FDA data

SOMATOM Pro.Pulse

Primary DI
04056869973500
Brand
SOMATOM Pro.Pulse
Company
Siemens Shanghai Medical Equipment Ltd.
Model
11594788
Published
2025-11-30
Public version status
New
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
K232206000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232206000SOMATOM Pro.PulseSiemens Medical Solutions USA, Inc.2023-12-06JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056869973500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056869973500040568699735004056869973500

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+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
04056869226545MULTIX Impact11020788110207882020-09-23
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
04056869010335Somatom Perspective104955682016-09-24
04056869010342Somatom Perspective SSME108916662016-09-24
04056869295541SOMATOM X.cite115012002025-11-30
04056869295558SOMATOM X.ceed115012012025-11-30
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
04056869019888Multix Fusion VA10107466652016-09-24
04056869019895Multix Fusion VA30107466672016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953147481RevolutionGE Medical Systems, L.L.C.JAK2026-11-03
04547410575392Synapse 3DFUJIFILM CORPORATIONJAK2026-10-30
08800025300374AVIEW Aorta MetricsCORELINE SOFT CO.,LTD.JAK2026-10-29
M722CD26272CA252790ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2026-10-28
00198953050996SnapShot FreezeGE Medical Systems, L.L.C.JAK2026-10-19
03760305400246DUAL SIDED NEEDLE GUIDEQUANTUM SURGICALJAK2026-10-19
03760305400277PATIENT REFERENCE 2.0QUANTUM SURGICALJAK2026-10-19
19356870000045CAC4DMEDICAL LIMITEDJAK2026-10-13
19356870000090LDA4DMEDICAL LIMITEDJAK2026-10-13
00860016243804C-beamPulmera, Inc.JAK2026-10-10
00884838120433SmartCTPhilips Medical Systems Nederland B.V.JAK2026-09-28
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-09-21
00860015781925Bunkerhill Contrast AVCBunkerhill Health Inc.JAK2026-09-16
00884838129559CT Areta RT/Rembra RT UpgradesPhilips Healthcare (Suzhou) Co., Ltd.JAK2026-08-21
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-06-05
10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.JAK2026-06-02
00860015781918iCAC DeviceBunkerhill Health Inc.JAK2026-05-31
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.JAK2026-05-27
00860015781901CAC (Gated) AlgorithmBunkerhill Health Inc.JAK2026-05-13
00850025268424Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-05-12
00198953085950PhotonovaGE Medical Systems, L.L.C.JAK2026-05-11
00884838129528CT RembraPhilips Healthcare (Suzhou) Co., Ltd.JAK2026-04-03
00884838129535CT Rembra RTPhilips Healthcare (Suzhou) Co., Ltd.JAK2026-04-03
00884838129542CT Areta RTPhilips Healthcare (Suzhou) Co., Ltd.JAK2026-04-03
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