Ultrasound System

Model number 10433816. serial numbers 401100 to 401400.

Radiology Devices

2

No

Worldwide Distribution - USA and the countries of Australia, Austria, Belarus, Canada, Ecuador, Finland, France, Georgia, Germany, India, Iraq, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Nigeria, P.R. China, Philippines, Portugal, Republic Korea, Russian Fed., Saudi Arabia, Serbia, South Africa, Spain, Suriname, Sweden, Taiwan, Turkey, U.A.E. and United Kingdom.

ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. || The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Serial Numbers: 400935 400140 400532 400580 400582 400592 400597 400635 400643 400652 400685 400686 400733 400737 400746 400752 400753 400771 400777 400784 400833 400919 400499 400896 400809 400296 400111 400319 400793 400699 400849 400816 400213 400212 400215 400251 400254 400407 400560 400670 400713 400722 400729 400730 400731 400734 400764 400766 400815 400920 400945 400149 400289 400341 400444 400510 400547 400562 400575 400732 400779 400904 400936 400939 400980 400987 401009 400321 400549 400922 400125 400199 400200 400043 400755 400808 400926 400426 400756 400806 400950 400424 400566 400711 400727 400801 400834 400911 400927 400933 400827 400127 400637 400642 400205 400880 400690 400745 400778 400802 400240 400591 400432 400780 400785 400819 400824 400825 400826 400838 400842 400844 400845 400863 400869 400871 400910 400937 400938 400724 400846 400973 400219 400300 400158 400159 400172 400181 400182 400187 400191 400192 400211 400249 400250 400279 400298 400301 400339 400512 400544 400579 400588 400590 400688 400738 400739 400741 400798 400812 400761 400837 400841 400850 400655 400839 400870 400879 400917 400578 400278 400423 400563 400606 400769 400901 400116 400165 400178 400214 400262 400266 400274 400275 400271 400414 400420 400430 400616 400760 400823 400876 400915 400928 400934 400253 400403 400412 400498 400581 400728 400765 400189 400897 400924 400908 400796 400836 400840 400946 400948 400957 400963 400218 400277 400856

Radiology Devices

2

No

Worldwide Distribution -- US and Albania, Australia, Austria, Bangladesh, Bulgaria, Canada, Colombia, Denmark, Ecuador, Egypt, France, Germany, Hungary, Iceland, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mauritius, Mexico, Netherlands, P.R. China, Philippines, Portugal, Rep. of Yemen, Republic Korea, Russian Fed., San Marino, Saudi Arabia, Singapore, Spain, Suriname, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom, and Venezuela.

ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. || The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications.

Model number 10433816 between software version VA16A and VA30A: US Serial numbers: 400930 401216 401375 401343 401049 400538 401115 400572 400464 401346 400196 401030 401246 400222 400455 400457 401090 401078 400318 401345 400668 400667 401158 400545 401022 401184 401308 401141 401311 400462 400467 400460 400461 401383 400466 401149 401300 400479 400493 400519 400861 400117 401070 400907 400740 400552 400454 401204 400530 400814 400818 400835 400900 400810 400811 401155 401156 400736 401279 401280 400220 400221 400742 400913 401351 400069 400326 400123 400137 400197 400234 400152 401322 401323 401327 400967 400974 400884 400795 401265 401266 401258 400848 400874 400883 400175 401348 400759 400226 400885 400757 400472 400536 401278 400236 400629 400640 401384 400800 400768 400775 400679 400680 400269 400483 400484 401234 401256 401003 401013 401014 400886 400890 400898 400794 400797 400978 401023 401025 400940 400954 400955 400992 400153 400554 401061 401328 400914 400715 400065 401169 401174 400770 401533 400958 401271 401286 401237 400475 401187 400970 400693 400589 401305 401075 401031 400291 400676 400678 400665 400683 401257. ROW serial numbers: 400935 400604 400682 400597 400833 400140 400753 401016 400166 400582 400983 401036 400784 400919 401376 401159 400186 400499 400896 400809 401160 400774 400282 400758 400723 401532 400402 400633 400296 400111 400319 400515 400942 400793 400343 400849 401400 400816 401143 400216 400212 400713 400215 400730 400734 401021 400920 401140 401239 401128 401052 400815 400766 401133 401018 400729 400731 400213 400903 401334 401048 401056 400722 401273 401225 401210 400904 401229 400980 400961 400941 400325 400562 400242 400444 400149 400547 400939 400510 401050 401142 400779 400341 400289 400987 401009 400321 400549 401077 400922 400702 400043 401329 401253 401295 400755 400808 400926 400150 401119 400806 400426 400428 400429 400756 401312 401192 401126 400711 401293 400566 400977 401079 400551 401219 400696 400834 400500 401276 401238 400207 401242 401317 401349 400933 401218 401199 400115 400418 400416 400422 400599 400600 401240 401215 400608 400601 401313 401068 400927 400424 400421 400185 400827 400127 400642 401396 400880 400205 401251 400690 400745 401074 401203 400802 400778 400614 400524 400523 400240 400591 401324 400469 401046 401535 401483 401834 400627 401340 401032 401264 400819 401716 401058 401062 400113 400241 400825 401357 401779 401672 401421 401717 401778 401167 401310 400328 400910 401222 401482 401202 401740 400869 401059 401413 401738 401419 401206 401416 401212 401828 401486 401170 400598 401057 400677 400826 401468 400332 400824 401352 400607 401702 401164 400842 401076 400419 400323 401703 401263 401201 400329 401354 401485 401341 401679 401531 401299 401221 400859 401162 401053 401097 400785 401298 401714 401715 401205 400644 401484 401742 400602 401670 400237 400432 401790 401829 401414 400413 400938 400625 401739 400335 400976 401168 400330 401418 401417 401682 401339 400525 400714 401095 401677 401166 400333 401792 401094 401172 401480 401701 400838 400971 401415 400434 400845 401479 401671 400906 401171 400863 401296 400706 400871 401789 401262 401534 401420 401675 400286 400780 401051 400256 400937 401353 400327 401831 401318 400724 400973 400490 400219 401039 400966 401017 400300 400201 401183 401195 401026 401145 401207 400739 400761 400187 400544 400741 400339 400632 401331 400494 400805 401129 400161 400537 400211 400159 400160 400181 401146 401153 400249 400248 400298 400301 400087 401200 400192 401220 400170 400184 400812 401085 401082 401087 401178 400718 400837 400841 400750 400751 400705 400561 400850 400542 400417 400574 400917 401151 400559 400571 401147 401211 401228 401230 401233 400255 401301 400839 400748 400870 400879 401231 401148 400585 401019 401024 401321 401277 400645 400606 400692 400521 400725 400769 400423 400563 400943 400701 401332 400928 400934 400823 400165 400765 400728 401042 400189 401154 400969 400897 400924 400908 400587 401086 400646 400796 401084 401306 400619 401000 400946 400948 400957 400963 401185 400603 401127 400476 401197 400856.

Radiology Devices

2

No

Worldwide Distribution - US Distribution and to the countries of : Albania, Angola, Armenia, Australia, Austria, Bangladesh, Belarus, Bolivia, Bosnia Herzog, Brazil, Brunei, Bulgaria, Canada, Colombia, Czech Republic, Ecuador, Egypt, Finland, France, Germany, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Lithuania, Malaysia, Maldives, Mauritius, Mexico, Netherlands, Nigeria, Oman, P.R. China, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed, San Marino, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Suriname, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom and Venezuela

ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. || Model number 10433816: || The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

Model s5i. Part number: 806300-020.

Radiology Devices

2

No

Worldwide Distribution-US (nationwide) and regions in Europe and the countries of Japan, Canada, South Africa, Taiwan, Thailand, Singapore, Philippines, Australia, New Zealand, El Salvador, Malaysia, Mexico, Lebanon, Kuwait, South Korea, Kenya, Jordan, Iran, India, Israel, Hong Kong, Egypt, Algeria, Dominican Republic, Costa Rica, Chile, Brazil, Bolivia, and Argentina

Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; || Model s5i || Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature

Model s5. Part numbers: 804200-002 and 804200-014

Radiology Devices

2

No

Worldwide Distribution-US (nationwide) and regions in Europe and the countries of Japan, Canada, South Africa, Taiwan, Thailand, Singapore, Philippines, Australia, New Zealand, El Salvador, Malaysia, Mexico, Lebanon, Kuwait, South Korea, Kenya, Jordan, Iran, India, Israel, Hong Kong, Egypt, Algeria, Dominican Republic, Costa Rica, Chile, Brazil, Bolivia, and Argentina

Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; || Model s5. || Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature