1、 胃镜室 Dndoscope Laboratory神经内科 Neurology Department肿瘤外科 Oncological SurgerySCT 室 SCt Laboratory人工肾室 Hemodialyses Room介入科 Invasive Technology Department神经外科 Neurological Surgery超声诊断科 UItrasonic Diagnosis DeparmentDSA 室 DSA Room呼吸科 Pneumology Department骨科 Orthopedics Department超声多谱勒室 UItrasonic Doppler
2、 Laboratory血液净化室 Laminar Airflow (LAF) Room肾内科 Urology Department小儿外科 Pediatric Surgery核医学科 Isotopic Laboratory高压氧仓室 Hyperbaric Chamber小儿科 Pediatrics Department整形科 Plastic SurgeryECT 室 ECT Laboratory院内感染监控室 Nosocomial Infection Monitory中医科 Traditional Chinese Medicine Department烧伤科 Department of Bur
3、n供应室 Supply House血液成份分离室 Cytopheresis Laboratory高干病房 Senior Officials inpatient WardUrine Analyzer 尿液分析仪 blood sugar（glucose ） analyzer 血糖分析仪 test strip 测试条 reagent 试剂 Semi-automatic Biochemical Analyzer 半自动生化分析仪 Automatic Blood Cell Analyzer 全自动血细胞分析仪 Urine sediments analyzer 尿沉渣 Bio-safety Cabinet
4、 生物安全柜 Incubator 培养箱 High Frequency Electrotome 高频电刀 shadowless lamp 无影灯 High speed refrigerated centrifuge 高速冷冻离心机 hot air sterilizer 热空气消毒箱 microbiological incubator 微生物培养箱 Halogen light 卤素灯 disposable sterile injector 一次性无菌注射针 injection set 注射器 disposable venous infusion needle 一次性静脉输液针 disposabl
5、e infusion set 一次性使用输液器 blood transfusion set 输血器 infusion bag 液袋 urine drainage bag 集尿袋 blood bag 血袋 medical catheter 医用导管 stainless steel needle 不锈钢医用针管 blood taking needle 采血针 needle destroyer 针头销毁器 automatic packer 自动纸塑包装机 scalp vein set 头皮针 uniprocessor version 单机版 network version 网络版 macromole
6、cule-solvent 高分子溶解的 macromolecule cold accumulation 高分子蓄冷 cold treatment 冷疗法 ice pack 冰袋 eyeshade 眼罩 Medical injection pump 医用灌注泵 lithotrite 碎石机 extracorporeal shock wave lithotrite 体外冲击碎石机 Ballistic intracroporeal lithotrite 气压冲击体内碎石机 Laparoscope 腹腔镜 Urology 泌尿外科 kidney stones 肾结石 Multi-parameter m
7、onitor, 多参数监护仪 maternal monitor/fetal monitor 母亲/ 胎儿监护仪 ICU monitor 重症监护仪 anesthetic equipment 麻醉机 respirator 呼吸机 electronic colposcope 电子阴道镜 smog absorber 烟雾吸收器 digital film room 数字胶片室 Permanent Magnet Open Magnetic Resonance system 永磁开放式磁共振系统 Ultrasonic Color Doppler Diagnostic system 彩色超声多普勒诊断系统
8、Mobile CT system 移动 CT 系统 X-ray Mammary Machine 乳腺 X 线机 Mammography 乳腺 high precision Stereotaxic 高精度脑立体定向仪 portable Type-B ultrasonic 便携式 B 超 Sterilization and Disinfection Equipment 消毒灭菌设备 Radiotherapeutic equipment.放射疗法设备 pharmaceutical equipments.制药设备 horizontal pressurized steam sterilizer 普通卧式
9、压力蒸汽灭菌器 medical electronic linear accelerator 医用电子直线加速器 high frequency X-rays diagnostic machine 高频 X 射线诊断机 simulated positioner 模拟定位机 high frequency mobile X-rays machine 高频移动 X 射线机 联邦食品、药品和化妆品法（Federal Food, Drug, and Cosmetic Act，FDCA）第 510（k）节的豁免限制Limitations of exemptions from section 510(k) of
10、 the Federal Food, Drug, and Cosmetic Act (the act)B 亚部心血管诊断器械（Cardiovascular Diagnostic Devices）心律失常探测器和警报器(包括 ST 段测量和警报)Arrhythmia detector and alarm (including ST-segment measurement and alarm)血压警报器 Blood pressure alarm血压计算机Blood pressure computer870.1120血压袖带Blood pressure cuff非侵入式血压测量系统Noninvasi
11、ve blood pressure measurement system 静脉血压计Venous blood pressure manometer诊断用血管内导管Diagnostic intravascular catheter连续式冲洗导管Continuous flush catheter电极记录导管或电极记录探针Electrode recording catheter or electrode recording probe光纤式血氧计导管Fiberoptic oximeter catheter导流导管Flow-directed catheter经皮导管Percutaneous cathe
12、ter腔内心音导管系统Intracavitary phonocatheter system可操纵导管Steerable catheter可操纵导管控制系统Steerable catheter control system导管套管Catheter cannula经皮插入导管用的血管扩张器Vessel dilator for percutaneous catheterization导管导线Catheter guide wire导管插入器Catheter introducer 导管球囊修理工具盒Catheter balloon repair kit示踪微球体Trace microsphere导管尖端
13、封闭器Catheter tip occluder导管探针Catheter stylet套管针Trocar可编程的诊断用计算机Programmable diagnostic computer预编程的单功能诊断用计算机Single-function, preprogrammed diagnostic computer光密度计Densitometer血管造影注射器和注射管Angiographic injector and syringe指示剂注射器Indicator injector注射器的注射管制动器Syringe actuator for an injector体外可编程起搏器脉冲发生器Exte
14、rnal programmable pacemaker pulse generator抽缩式输液泵Withdrawal-infusion pump听诊器Stethoscope热稀释探头 Thermodilution probeC 亚部心血管监测器械（Cardiovascular Monitoring Devices）生物电位放大器和信号调节器Biopotential amplifier and signal conditioner传感器信号放大器和调节器Transducer signal amplifier and conditioner心血管血液流量计Cardiovascular blood
15、 flowmeter血管外血流探头Extravascular blood flow probe监测器(包括心率计和心率警报器)Cardiac monitor (including cardiotachometer and rate alarm)尖端心动描记器(心振动图仪)Apex cardiograph (vibrocardiograph)心冲击描记器Ballistocardiograph超声波心动图仪Echocardiograph心电图仪Electrocardiograph心电图仪导线转换接合器Electrocardiograph lead switching adaptor心电图仪电极El
16、ectrocardiograph electrode 心电图仪表面电极检测器Electrocardiograph surface electrode tester心音图仪Phonocardiograph心电向量图仪Vectorcardiograph医用阴极射线管显示器Medical cathode-ray tube display信号隔离系统Signal isolation system在线隔离监视器Line isolation monitor便携式漏电流警报器Portable leakage current alarm动脉搏动描记器Oscillometer光电血氧计Oximeter耳光电血氧
17、计Ear oximeter阻抗式静脉搏动描记器Impedance phlebograph阻抗式体积描记器Impedance plethysmograph水压式、气动式或光电式体积描记器Hydraulic, pneumatic, or photoelectric plethysmographs医用磁带记录器Medical magnetic tape recorder纸质图表记录器Paper chart recorder尖端心动描记传感器Apex cardiographic transducer血管外血压传感器Extravascular blood pressure transducer心音传感器
18、Heart sound transducer导管顶端压力传感器Catheter tip pressure transducer超声式传感器Ultrasonic transducer脉管闭塞传感器Vessel occlusion transducer患者传感器和电极电缆(包括连接器)Patient transducer and electrode cable (including connector)射频生理信号发送器和接收器Radiofrequency physiological signal transmitter and receiver电话式心电图仪发送器和接收器Telephone el
19、ectrocardiograph transmitter and receiverD 亚部心血管修复器械（Cardiovascular Prosthetic Devices） 医疗器械之窗 血管夹Vascular clip腔静脉夹Vena cava clip动脉栓塞器械Arterial embolization device心血管内过滤器Cardiovascular intravascular filter血管移植假体Vascular graft prosthesis聚丙烯、聚对苯二甲酸乙酯或聚四氟乙烯制成的心内补片或纱布Intracardiac patch or pledget made
20、of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene大动脉内球囊和控制系统Intra-aortic balloon and control system心室旁路(辅助)器械Ventricular bypass (assist) device体外起搏器脉冲发生器External pacemaker pulse generator植入式起搏器脉冲发生器Implantable pacemaker pulse generator起搏器导线接合器Pacemaker lead adaptor起搏器发生器功能分析仪P
21、acemaker generator function analyzer 间接式起搏器发生器功能分析仪Indirect pacemaker generator function analyzer起搏器聚合体网袋Pacemaker polymeric mesh bag起搏器充电器Pacemaker charger心血管永久性或临时性起搏器电极Cardiovascular permanent or temporary pacemaker electrode起搏器测试磁铁Pacemaker test magnet起搏器程序器Pacemaker programmers起搏器修复或替换材料Pacemak
22、er repair or replacement material起搏器电极功能检测器Pacemaker electrode function tester起搏器维修工具Pacemaker service tools瓣环成形术环Annuloplasty ring颈动脉窦神经刺激器Carotid sinus nerve stimulator心脏瓣膜替代品Replacement heart valve心脏瓣膜假体支架Prosthetic heart valve holder 医疗器械之窗 心脏瓣膜假体筛选器Prosthetic heart valve sizerE 亚部心血管手术器械（Cardi
23、ovascular Surgical Devices）心肌膜炎活组织检查器械Endomyocardial biopsy device心肺旁路附属设备Cardiopulmonary bypass accessory equipment心肺旁路气泡探测器Cardiopulmonary bypass bubble detector心肺旁路血管导管、套管或管路Cardiopulmonary bypass vascular catheter, cannula, or tubing心肺旁路心肺机控制台Cardiopulmonary bypass heart-lung machine console心肺旁路
24、消泡器Cardiopulmonary bypass defoamer心肺旁路热交换器Cardiopulmonary bypass heat exchanger心肺旁路温度控制器Cardiopulmonary bypass temperature controller心肺旁路动脉血过滤器Cardiopulmonary bypass arterial line blood filter心肺旁路心切开术抽吸管路血液过滤器 Cardiopulmonary bypass cardiotomy suction line blood filter心肺旁路前过滤器Cardiopulmonary prebypa
25、ss filter心肺旁路接合器、旋塞阀、汇流管或配件Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting心肺旁路气体控制装置Cardiopulmonary bypass gas control unit心肺旁路冠状动脉压力计Cardiopulmonary bypass coronary pressure gauge心肺旁路脉动流发生器Cardiopulmonary bypass pulsatile flow generator心肺旁路即时血气监测仪Cardiopulmonary bypass on-line blood
26、gas monitor心肺旁路液面自动检测监视器和/或控制器Cardiopulmonary bypass level sensing monitor and/or control心肺旁路氧合器Cardiopulmonary bypass oxygenator非滚筒型心肺旁路血液泵Nonroller-type cardiopulmonary bypass blood pump滚筒型心肺旁路血液泵Roller-type cardiopulmonary bypass blood pump心肺旁路泵速度控制器Cardiopulmonary bypass pump speed control心肺旁路泵管
27、路Cardiopulmonary bypass pump tubing心肺旁路血液储存器Cardiopulmonary bypass blood reservoir心肺旁路内嵌式血气传感器Cardiopulmonary bypass in-line blood gas sensor心肺旁路心切开术返回吸管Cardiopulmonary bypass cardiotomy return sucker心肺旁路心脏内抽吸控制器Cardiopulmonary bypass intracardiac suction control血管夹Vascular clamp外科手术血管扩张器Surgical ve
28、ssel dilator心血管手术器具Cardiovascular surgical instruments管腔内动脉剥离器Intraluminal artery stripper体外静脉剥离器External vein stripperF 亚部 心血管治疗器械（Cardiovascular Therapeutic Devices）患者照料吸引装置Patient care suction apparatus栓子切除导管Embolectomy catheter房隔造口导管Septostomy catheter体外心脏挤压器External cardiac compressor体外反搏装置External counter-pulsating device
