Ultrasound

All Serial numbers

Radiology Devices

2

No

Worldwide Distribution: US (nationwide) including Washington, D.C., and countries of: Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Bermuda, Bolivia, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mayotte, Mexico, Monaco, Mongolia, Morocco, Myanmar, Netherlands, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, State of, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿¿union, Romania, Russia , Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, and Viet Nam.

EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, EPIC 7GC, and EPIQ 7W. || Diagnostic Ultrasound System for ultrasound imaging in abdominal, cardiac adult, cardiac other (fetal), cardiac pediatric, cerebral vascular, cephalic (adult), cephalic (neonatal), fetal/obstetric, gynecological, intraoperative (vascular), intraoperative (cardiac), musculoskeletal (conventional), musculoskeletal (superficial), other: urology, pediatric, peripheral vessel, small organ (breast, thyroid, testicle), transesophageal (cardiac), trans rectal, transvaginal.

Serial Numbers: 5007750, 5008004, 5007734,5007742, 5007596, and50074277

Radiology Devices

2

No

Worldwide Distribution - US to TX, FL, and MA. Internationally to Australia

BK Medical ApS Ultrasound System Scanner bk2300 - || Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. || The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN

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Radiology Devices

2

No

Distributed to the states of: AZ, CA, FL, HI, IL MA, MD, ME, MN, MO, NC, NJ, NY, OH, PA, SC, TN, and TX.

Arietta 70 Ultrasound System || Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation.

Serial Numbers: G110307, H110482, H110484, H110487, H110489, G110334, G110338, G110404, G110296, G110358, G110340, G110341, G110407, G110409, H110432, G110345, H110450, G110391, H110476, H110443, H110446, G110400, H110483, G110394, G110406, H110411,  H110497, G110360, G110363, G110364, G110371, G110366, G110368,  G110372, H110434, H110447, G110380, H110455, G110298, H110445,  H110449, H110461, G110292, G110346, G110365, H110494, H110495,  H110474, G110376, G110319, G110328, H110473, H110413, H110414, H110427, H110453, H110454, H110415, G110312, G110321, H110467,  H110471, H110412, G110289, G110303, G110294, H110420, G110299,  G110300, H110448, H110452, G110386, G110331, H110451, H110493,  G110313, G110314, H110464, H110496, H110433, G110373, G110375,  G110317, H110431, H110417, G110291, G110302, G110369, G110378,  G110335, G110387, G110390, G110392, G110395, G110311, G110327,  G110332, G110382, G110355, G110357, G110287, G110320, H110435,  H110481, H110485, H110486, G110354, G110316, G110318, G110362,  G110393, H110498, H110456, H110457, H110459, G110337, G110356,  H110421, H110429, G110290, G110352, H110470, H110478, G110383,  G110384, G110361.

Gastroenterology-Urology Devices

2

No

Nationwide

Ultrasound Video Gastroscope, Model EG-3670URK, || The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.