Devices

Name Classification Manufacturer Risk Class Country Source
XenaLight system Century Medical Co., Ltd. Japan
Jarvik 2000 Implantable artificial heart system Century Medical Co., Ltd. Japan
Cannula flexure mate for extracorporeal circulation (Adapter Kit ADKN-04 for infusion of myocardial protective liquid) Izumi Kogyo Kogyo Co., Ltd. Japan
Sofit Vent Baby O2 Izumi Kogyo Kogyo Co., Ltd. Japan
(1) Mella HP Excellan Prime (Model HPO - 06 RHF - C, HPO - 06 H - C) (2) Mella HP Excellan TPC (Model: HPO - 06 RHF - CP, HPO - 06 H - CP) (3) Mella Excel Line Circuit N 2 (4) Mella Exceline Circuit TPC (5) Mella Excel Line Circuit HP 2 Izumi Kogyo Kogyo Co., Ltd. Japan
Hanako · IR catheter Hanako Medical Co., Ltd. Japan
Versatile blood circuit Japan Lifeline Co., Ltd. Japan
(1) Platinium ICD (2) Platinium CRT-D Japan Lifeline Co., Ltd. Japan
Cardiac rescue RQ - 5000 Japan Lifeline Co., Ltd. Japan
Diagnostic X-ray high voltage device UD 150 B - 40 SPT Shimadzu Corporation Japan
(1) Blood vessel imaging system BRANSIST safire (2) Angiography system Trinias (3) C arm type holding device for circulatory system MH - 300 Shimadzu Corporation Japan
Motion tracking system for radiotherapy device SyncTraX Shimadzu Corporation Japan
(1) Digital type X-ray general imaging system RADspeed safire (2) Diagnostic X-ray device RADspeed Pro (3) Digital type X-ray general imaging system DR-XD100 (4) Diagnostic X-ray device DR-XD101 X-ray device for FUJIFILM DR BENEO-Fx (6) Overhead traveling X-ray tube suspension device CH - 200 (7) Overhead traveling X - ray tube suspension device CH - 200 M Shimadzu Corporation Japan
Diagnostic X-ray device RADspeed Pro Diagnostic X-ray device DR-XD 101 Diagnostic X-ray high voltage device UD 150 B-40 Diagnostic X-ray high voltage device UD 150 L-40 Shimadzu Corporation Japan
(1) X-ray television system SONIALVISION safire 17 (2) X-ray television system SONIALVISION G 4 (3) Diagnostic X-ray high voltage device UD 150 B - 40 Shimadzu Corporation Japan
X-ray television system SONIALVISION G4 Shimadzu Corporation Japan
(1) Diagnostic X-ray device X'sy Pro (2) X-ray imaging table BK-1 T (3) X-ray imaging table BK-1 TM Shimadzu Corporation Japan
(1) Automatic biochemical analyzer CA - 400 (2) Automatic biochemical analyzer CA - 400 plus Furuno Electric Co., Ltd. Japan
Cellvizio 100 system INCREASE INC. Japan
Technical Carbide Bar Morita Corporation Japan
Ti Honeycomb Membrane Morita Corporation Japan
Kids Crown Morita Corporation Japan
(1) Ultrasonic diagnostic device Aplio i900 TUS - AI 900 (2) Ultrasonic diagnostic device Aplio i 800 TUS - AI 800 (3) Ultrasonic diagnostic device Aplio i 700 TUS - AI 700 (4) Ultrasonic diagnostic device Aplio i 600 TUS - AI 600 Toshiba Medical Systems Co., Ltd. Japan
(1) X-ray cardiovascular diagnostic system Infinix Celeve-i INFX-8000C (2) X-ray cardiovascular diagnostic system Infinix Celeve-i INFX-8000H (3) X-ray cardiovascular diagnostic system Infinix Celeve-i INFX-8000V Toshiba Medical Systems Co., Ltd. Japan
Toshiba Scanner Aquilion Precision TSX-304A Toshiba Medical Systems Co., Ltd. Japan