Siemens Medical Solutions USA, Inc.

Serial Numbers: 200190, 200191, 200281, 200287, 200366, 200481, 200519, 200577, 200699, 200738, 200759, 200761, 200830, 200836, 200851, 200855, 200857, 200874, 200878, 200925, 201002, 200909, 200966, 200220, 200187, 200218, 200663, 200524, 200395, 200291, 200850, 200854, 200875, 200965, 200178, 200103, 200104, 200118, 200143, 200183, 200200, 200210, 200686, 200694, 200852, 200889, 200908, 200927, 201005, 200849, 200834, 200835, 200839, 200211, 200696, 200859, 200926, 200660, 200661, 200687, 200719

Radiology Devices

2

No

Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Switzerland, China, Czech Republic, Germany, Denmark, Great Britain, Hong Kong, Indonesia, India, Italy, South Korea, Norway, Turkmenistan, and Taiwan

TEE Transducer V5M, when used with the Acuson S2000 Ultrasound System, software versions: VA15, VA15A or VA15B; Model Numbers: 10041461 (Acuson S2000) and 8263703 (V5M Transducer); || Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Mountain View, CA || Product is a medical device, a multi-purpose mobile, software controlled diagnostic ultrasound system with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. tis function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-mode, MMode, Pulsed(PW) Doppler mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or harmonic imaging and 3d/4d imaging on a flat panel display. The device system is intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides 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. The device is a multi frequency, multi plane, phased sector array transducer. In the TEE (transesophageal echocardiography process where the device fails, the transducer is introduced into the esophagus of the patient to obtain images of the heart structure.

Model Numbers begins with 1003, 1004, 059 and 086 with product version 5.0, and softeare version 200.0.079

Radiology Devices

2

No

Worldwide Distribution - United States (nationwide) and the countries of Australia, Austria, Azerbaijan, Brazil, Belarus, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Guatemala, Croatia, India, Indonesia, Italy, Jordan, Japan, Latvia, Malaysia, Mexico, Moldova, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.

Acuson Antares Ultrasound System || Diagnostic Ultrasound system

Material number: 10433816: Serial numbers:  82638701 82741703 84254503 84355608 84455108 84754522 84857919 91861815 84858401 84655617 91654526 83044913 90261810 90864208 01288401 61101009 61601024 81631208 83146817 83251905 83751103 83752419 84455113 84557302 84753934 84857907 85056212 91503602 93771403 94982205 83650009 90656713 95183003 84456707 84153940 84857908 84857918 84953903 92068501 92256206 82540305 84053927 83853304 84656203 94065109

Radiology Devices

2

No

Worldwide Distribution: USA and countries including: Australia, Belgium, Brazil, China, Czech Republic, Finland, France, Germany, India, Ireland, Italy, Japan, Kenya, Malaysia, Netherlands, Norway, Portugal, South Korea, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom.

4Z1c matrix array transducer which is used with ACUSON SC2000 ultrasound system. || Siemens Medical Solutions USA, Inc. || Business Unit Ultrasound || 1230 Shorebird Way || Mountain View, CA 94043 || Intended use: 4Z1 transducer is a special purpose ultrasound transducer designed to help clinicians perform adult echocardiography and pre-operative and intra-operative surgical assessments. Secondary applications include: pediatric, echocardiography, primarily benefiting older and larger pediatric populations, general abdominal and Pinta-operative pediatric abdominal imaging and peripheral vessel imaging.

Material Number: 10033682: Serial number of systems: 400212 400213 400215 400251 400405 400240 400089 400090 400104 400109 400149 400171 400289 400302 400334 400337 400183 400218 400209 400219 400259 400126 400247 400257 400260 400263 400281 400116 400165 400214 400420 400216 400253 400403 400412 400343 400185 400026 400044 400045 400084 400086 400088 400091 400102 400111 400114 400117 400118 400121 400124 400129 400132 400135 400139 400142 400143 400145 400146 400148 400156 400162 400168 400174 400176 400179 400202 400203 400206 400217 400220 400221 400222 400223 400224 400225 400227 400228 400229 400230 400232 400233 400234 400235 400236 400238 400239 400242 400243 400244 400258 400268 400269 400270 400272 400282 400287 400288 400290 400291 400293 400295 400297 400303 400304 400312 400314 400316 400336 400435 400449 400294 400127 400043 400125 400199 400200 400208 400113 400120 400237 400241 400332 400335 400413 400419 400158 400160 400161 400170 400172 400181 400182 400184 400187 400191 400201 400211 400249 400250 400299 400115 400155 400157 400207 400416 400424 400189 400195 400197 400166

Radiology Devices

2

No

Worldwide Distribution: USA and countries including: Australia, Belgium, Brazil, China, Czech Republic, Finland, France, Germany, India, Ireland, Italy, Japan, Kenya, Malaysia, Netherlands, Norway, Portugal, South Korea, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom.

ACUSON SC 2000 ultrasound system. || Siemens Medical Solutions USA, Inc. || Business Unit Ultrasound || 1230 Shorebird Way || Mountain View, CA 94043 || Intended use: SC2000 ultrasound system is intended for the following applications: Cardiac, neo-Natal and fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skeletal Conventional, and anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medial data obtained by a physician for clinical diagnosis purposes.

All units of this model.

Hematology and Pathology Devices

2

No

Worldwide distribution.

Siemens brand ACUSON S2000 Ultrasound System with software versions: || VA10, VA10A, VA10B, VA10C, VA15; Model Number: 10041461; || Product is manufactured and distributed by Siemens Medical Solutions USA, Inc. Ultrasound Business Unit, Mountain View, CA || The ACUSON SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications.