Siemens Healthcare GmbH

Address:Am Studio 1,Berlin,DE

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, image processing, radiological (LLZ) (6) System, x-ray, tomography, computed (JAK) (2) Digital Breast Tomosynthesis (OTE) (1) System, x-ray, stationary (KPR) (1)

Premarket Exempt

No Yes

Clear

Tomosynthesis option - 04056869001005 Catalog Number :

Device Description : Option to the MAMMOMAT Inspiration FFDM system to acquire tomosynthesis images f Option to the MAMMOMAT Inspiration FFDM system to acquire tomosynthesis images for mammography

Device Class : 3

Duns Number: 313217003

Premarket Exempt : No

Product Code : OTE

Prescription Use : No

Device Count : 1

syngo.plaza - 04056869001081 Catalog Number :

Device Description : syngo.plaza VB20Aproduct label - about box

Device Class : 2

Duns Number: 313217003

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

System SOMATOM Definition AS - 04056869003665 Catalog Number :

Device Class : 2

Duns Number: 313217003

Premarket Exempt : No

Product Code : JAK

Prescription Use : No

Device Count : 1

Ysio Max - 04056869004273 Catalog Number :

Device Description : Radiography System

Device Class : 2

Duns Number: 313217003

Premarket Exempt : No

Product Code : KPR

Prescription Use : No

Device Count : 1

syngo.plaza - 04056869004365 Catalog Number :

Device Description : syngo.plaza VB20AStock Keeping Unit C - packaging labelThis unit contains the fo syngo.plaza VB20AStock Keeping Unit C - packaging labelThis unit contains the following registered Medical Device:(1) syngo.plaza - GTIN 04056869001081

Device Class : 2

Duns Number: 313217003

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

syngo MultiModality Workplace - 04056869004631 Catalog Number :

Device Description : "syngo.MMWP VE61B Product label - about box"

Device Class : 2

Duns Number: 313217003

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

syngo.via WebViewer - 04056869004754 Catalog Number :

Device Description : syngo.via WebViewer VA12A/VA13A product label - about box

Device Class : 2

Duns Number: 313217003

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

syngo.plaza - 04056869005751 Catalog Number :

Device Description : "syngo.plaza VB10B product label - about box"

Device Class : 2

Duns Number: 313217003

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

syngo.plaza - 04056869005782 Catalog Number :

Device Description : syngo.plaza VB10BStock Keeping Unit C - packaging labelThis unit contains the fo syngo.plaza VB10BStock Keeping Unit C - packaging labelThis unit contains the following registered Medical Device:(1) syngo.plaza - GTIN 04056869005751

Device Class : 2

Duns Number: 313217003

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

CFK TABLETOP - 04056869005799 Catalog Number :

Device Class : 2

Duns Number: 313217003

Premarket Exempt : Yes

Product Code : JAK

Prescription Use : No

Device Count : 1

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