PRODUCT SIEMENSE – 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 170 kg. 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. . Generator cabinet approx. 440 kg. Patient table approx. 300 kg. Bucky wall stand (non-tilting) approx. 185 kg.X-RAY STATIONARY ANALOG MULTIX FUSION ANALOG Factory of Origin Manufacturer: China. Tube column stand 245 kg. Generator 132 kg (without pre- transformer). Room size min 3. Wall stand 245 kg.7 m .5 m x 4.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). 300 kg. Bucky wall stand (non-tilting) approx. 185 kg. 170 kg. MULTIX FUSION DIGITAL Country of Origin China Factory of Origin China. 440 kg. . Generator cabinet approx. Patient table approx. 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. 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) . China. Korea.X – RAY FLUOROSCOPY ANALOG RADIOFLUOROSCOPY SYSTEM SIEMENS LUMINOS RF CLASSIC Country of Origin China Factory of Origin China. Taiwan. Canada. 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. Function Analog Radiofluoroscopy system (550 mA) . Japan. Canada and Japan Function Digital Fluoroscopy system with 33 cm Image Intensifier and an analog ceiling-mounted 2nd X-ray tube .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. DIGITAL OVERTABLE FLUOROSCOPY SYSTEM LUMINOS FUSION FD Country of Origin China Factory of Origin China. Canada and Japan Function Digital Overtable Fluoroscopy system with 43 x43 cm Flat Detector . 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. 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) . 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. Room Size min. 3m x 3m .MAMMOGRAPHY DIGITAL MAMMOMAT INSPIRATION Country of Origin Germany Factory of Origin Siemens AG. Control Desk with Radiation Shield 124kg. Germany OEM no Product Registration AKL 21501511517 FDA Clearance NA CE Mark Yes IEC Compliance IEC 60601-1 Where Marketed Worldwide .ANALOG MAMMOMAT SELECT Model/Type Mammomat Select Country of Origin Germany Factory of Origin Siemens AG. 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 . 5 cm x 80 cm x 173 cm.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. 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 . 2 PROBES ACUSON SC2000 Country of Origin United State Factory of Origin United State Product Registration 21501904505 .USG AUTOMATED PREMIUM ENCHOCARDIOGRAPHY. 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 .