PRODUCT SIEMENS

E CATALOQ

MOBILE X RAY
ANALOG

POLYMOBIL PLUS

Country of Origin Spain

Factory of Origin Siemens AG, Germany

OEM no

Product Certification ISO 13485

Product Registration AKL 21501602200

FDA Clearance no

CE Mark yes

IEC Compliance IEC 60601

Locally Content no

Where Marketed Worldwide except USA

Function Analog mobile X-ray system 300 mA

Other Information 130.5 x 63.1 x 132.5 cm, 171 kg

 MOBILLET XP ECO

Country of Origin Spain

Factory of Origin Siemens AG, Germany

OEM N/A

Product Certification ISO 13485

Product Registration 21501603227

FDA Clearance N/A

CE Mark Yes

IEC Compliance IEC 60601

Locally Content N/A

Where Marketed Worldwide

Function Analog mobile X-Ray system

with 400 mA

Other Information 98.7 x 57.5 x 155 cm, 206 kg

DIGITAL

MOBILETT MIRA

Country of Origin Spain

Factory of Origin Siemens AG, Germany
OEM no
Product Certification ISO 13485
Product Registration AKL 21501515917
FDA Clearance yes
CE Mark yes
IEC Compliance IEC 60601
Locally Content No
Where Marketed Worldwide
Function Mobile X-ray System with
450 mA
X-RAY STATIONARY
ANALOG

MULTIX FUSION ANALOG

Factory of Origin Manufacturer: China, Siemens

Shanghai Medical Equipment
OEM no
Product Certification ISO 13485
Product Registration AKL 21501310851
FDA Clearance yes
CE Mark yes
IEC Compliance IEC 60601
Locally Content no
Where Marketed Worldwide
Function Analog Ceiling-mounted
Radiography System (550 mA)

Other Information Ceiling-mounted support (3 m)

approx. 300 kg, Patient table
approx. 440 kg, Bucky wall stand
(non-tilting) approx. 185 kg,
Generator cabinet approx. 170 kg.
DIGITAL

MULTIX SELECT DR

Country of Origin China

Factory of Origin China
OEM No
Product Certification ISO 13485
Product Registration AKL 21501212379
FDA Clearance Yes
CE Mark Yes
IEC Compliance IEC 60601
Locally Content No
Where Marketed Worldwide
Function Digital Floor-mounted General X-
ray (550 mA)
Other Information System 596 kg (not including wall
stand), Tube column stand 245 kg,
Generator 132 kg (without pre-
transformer), Wall stand 245 kg,
Room size min 3.5 m x 4.7 m
 MULTIX FUSION DIGITAL

Country of Origin China

Factory of Origin China, Siemens Shanghai Medical
Equipment
OEM no
Product Certification ISO 13485
Product Registration AKL 21501310851
FDA Clearance yes
CE Mark yes
IEC Compliance IEC 60601
Locally Content no
Where Marketed Worldwide
Function Digital Ceiling-mounted
Radiography System (550 mA)
Other Information Ceiling-mounted support (3 m)
approx. 300 kg, Patient table
approx. 440 kg, Bucky wall stand
(non-tilting) approx. 185 kg,
Generator cabinet approx. 170 kg.
 YSIO 2 DETECTOR

Country of Origin Germany

Factory of Origin Germany
Product Certification ISO 13485
Product Registration AKL 21501112639
FDA Clearance yes
CE Mark yes
IEC Compliance IEC 60601
Locally Content no
Where Marketed Worldwide
Function Digital Ceiling-mounted general
radiography system (650 mA)
X RAY FLUOROSCOPY
ANALOG RADIOFLUOROSCOPY SYSTEM

SIEMENS LUMINOS RF CLASSIC

Country of Origin China

Factory of Origin China, Siemens Shanghai Medical
Equipment
OEM No
Product Certification ISO 13485
Product Registration AKL 21501808043
FDA Clearance No
CE Mark Yes
IEC Compliance IEC 60601
Locally Content No
Where Marketed Worldwide except US, Canada,
China, Japan, Korea, Taiwan.
Function Analog Radiofluoroscopy system
(550 mA)
DIGITAL FLUOROSCOPY SYSTEM WITH IMAGE INTENSIFIER AND
AN ANALOG CEILLING-MOUNTED 2nd X-RAY TUBE

LUMINOS FUSION II

Country of Origin China

Factory of Origin China, Siemens Shanghai Medical
Equipment
OEM No
Product Certification ISO 13485
Product Registration AKL 21501211561
FDA Clearance No
CE Mark Yes
IEC Compliance IEC 60601
Locally Content No
Where Marketed Worldwide except USA, Canada
and Japan
Function Digital Fluoroscopy system with 33
cm Image Intensifier and an analog
ceiling-mounted 2nd X-ray tube
DIGITAL OVERTABLE FLUOROSCOPY SYSTEM

LUMINOS FUSION FD

Country of Origin China

Factory of Origin China, Siemens Shanghai Medical
Equipment
OEM No
Product Certification ISO 13485
Product Registration AKL 21501211561
FDA Clearance No
CE Mark Yes
IEC Compliance IEC 60601
Locally Content No
Where Marketed Worldwide except USA, Canada
and Japan
Function Digital Overtable Fluoroscopy
system with 43 x43 cm Flat
Detector
DIGITAL UNDERTABLE RADIOFLUOROSCOPY SYSTEM

LUMINOS AGILE

Country of Origin Germany

Factory of Origin Germany
OEM No
Product Certification ISO 13485
Product Registration AKL 21501510372
FDA Clearance Yes
CE Mark Yes
IEC Compliance IEC 60601
Locally Content No
Where Marketed Worldwide
Function Digital Undertable
Radiofluoroscopy System (650 mA
with 43 x 43 cm Flat Detector)
MAMMOGRAPHY
DIGITAL

MAMMOMAT INSPIRATION

Country of Origin Germany

Factory of Origin Siemens AG, Germany
OEM No
Product Certification ISO 13485
Product Registration AKL 21501903637
FDA Clearance Yes
CE Mark Yes
IEC Compliance IEC 60601
Locally Content No
Where Marketed Worldwide
Function Digital Mammography System
Other Information Examination Stand and Generator
350kg, Control Desk with Radiation
Shield 124kg.
Room Size min. 3m x 3m
ANALOG

MAMMOMAT SELECT

Model/Type Mammomat Select

Country of Origin Germany
Factory of Origin Siemens AG, Germany
OEM no
Product Registration AKL 21501511517
FDA Clearance NA
CE Mark Yes
IEC Compliance IEC 60601-1
Where Marketed Worldwide
CT- SCAN

CT-SCAN 2 SLICE

SOMATOM SPIRIT

Country of Origin China

Factory of Origin China
Product Registration 21501501833
Where Marketed Worldwide
CT-SCAN 16 SLICE

SOMATOM EMOTION EXCEL EDITION

Country of Origin China

Factory of Origin China
Product Registration 21501804926
Where Marketed World wide
CT-SCAN 64 SLICES

SOMATOM DEFINITION AS

Country of Origin Germany

Factory of Origin Germany
Product Registration AKL 21501803380
FDA Clearance Yes
CE Mark Yes
Where Marketed Worldwide
CT-SCAN 128 SLICE

SOMATOM PERSPECTIVE

Country of Origin Germany

Factory of Origin Germany
Product Registration AKL 21501310852
Where Marketed Worldwide
Function Diagnostic Imaging
Other Information Gantry dimention:
CT-SCAN DUAL SOURCE CT- 2 X 128 SLICE

SOMATOM DEFINITION FLASH

Model/Type CT SOMATOM Definition Flash (Dual

Source CT)
Country of Origin Germany
Factory of Origin Germany
Product Registration AKL 21501012802
FDA Clearance Yes
CE Mark Yes
Where Marketed Worldwide
POST PROCESSING

SYNGO.VIA

Country of Origin Germany

Factory of Origin Germany
Product Registration AKL 21501510560
Where Marketed worldwide
Function Post Processing
MRI

MRI 1,5 TESLA

MAGNETOM AVANTO

Country of Origin Germany

Factory of Origin Germany
Product Registration AKL 21501402356
Where Marketed worldwide
 MAGNETOM AERA

Country of Origin Germany

Factory of Origin Germany
Product Registration AKL 21501012976
Where Marketed Worldwide
MRI 3 TESLA
MAGNETOM SKYRA

Country of Origin Germany

Factory of Origin Germany
Product Registration AKL 21501012971
Where Marketed Worldwide
Function Diagnostic Imaging
ANGIOGRAPHY

ARTIS ZEE CEILING MOUNTED SYSTEM

Country of Origin Germany

Factory of Origin Germany
Product Registration AKL 21501804296
FDA Clearance K090745
CE Mark G1 12 05 52074 043
IEC Compliance Q1N 14 03 52074 060
Where Marketed Worldwide
Function Digital Subtraction Angiography
 ARTIS ZEE BIPLANE

Model/Type Angiography X-Ray System

Country of Origin Germany
Factory of Origin Germany
Product Registration AKL 21501113312
Where Marketed Worldwide
C-ARM
DIGITAL
ARCADIS ORBIC 3D

Country of Origin Germany

Factory of Origin Germany
Product Registration AKL 21501705565
FDA Clearance K042793
CE Mark G1120552074043
IEC Compliance Q1N140352074060 EN ISO
13485:2012/AC:2012
Where Marketed Worldwide
Function Mobile C-arm system
 ARCADIS VARIC

Country of Origin Germany

Factory of Origin Germany
Product Registration AKL 21501603061
Where Marketed Worldwide
ANALOG
SIREMOBIL COMPACT L

Country of Origin Germany

Factory of Origin Germany
Product Registration AKL 21501808585
FDA Clearance K963093
CE Mark G1120552074043
IEC Compliance Q1N140352074060 EN ISO
13485:2012/AC:2012
Where Marketed Worldwide
Function Mobile C-arm system
Other Information 171,5 cm x 80 cm x 173 cm,
138 kg
ULTRASONOGRAPHY (USG)

USG 2 PROBES
ACUSON P300

Country of Origin Italy

Factory of Origin Italy
Product Registration AKL 21501311342
FDA Clearance 4190-7-2012
CE Mark G1120249792029
IEC Compliance Q1N120249792028 ISO
13485:2003/AC:209
Where Marketed Worldwide
Function USG OK/ICU w/ 2 probes
USG 4D WITH 3 PROBES
ACUSON S1000

Country of Origin USA

Factory of Origin USA
OEM USA
Product Certification YES
Product Registration AKL 21501212655
FDA Clearance YES
CE Mark YES
Where Marketed Worldwide
USG OBGYN 4D PREMIUIM 5 PROBES

ACUSON S1000

Country of Origin United States

Factory of Origin United States
Product Registration 21501212655
USG 4D WITH 5 PROBES

ACUSON SC2000

Country of Origin USA

Factory of Origin USA
Product Certification YES
Product Registration AKL 21501904505
FDA Clearance 893-2-2012
CE Mark G1120249792029
IEC Compliance Q1N120249792028 ISO
13485:2003/AC:2009
Where Marketed WORLDWIDE
USG AUTOMATED PREMIUM ENCHOCARDIOGRAPHY- 2 PROBES

ACUSON SC2000

Country of Origin United State

Factory of Origin United State
Product Registration 21501904505
USG SHARING SYSTEM 4D AND CARDIAC 5 PROBES

ACUSON X-300

Factory of Origin United States

Country of Origin United States
Product Registration 21501700766
Where Marketed worldwide
USG ELASTOGRAPHY 3 PROBES

ACUSON X700

Model/Type USG Acuson X700 Elastography

with 3 pobes
Country of Origin Korea
Factory of Origin Korea
Product Registration AKL 21501310855
Where Marketed Worldwide
ESWL
MODULARIS VARIOSTAR

Country of Origin Germany

Factory of Origin Germany
Product Certification Yes
Product Registration AKL 20805901999
FDA Clearance K070799
CE Mark G1120552074043
IEC Compliance Q1N14035207460 EN ISO
13485:2012/AC:2012
Where Marketed Worldwide