Sonosite, Inc.

All SonoCalc IMT version 3.0

Radiology Devices

2

No

Nationwide, Kuwait, Mexico, South Africa, Chile, Spain, Japan, Puerto Rico, Australia. A list of 155 cases in which the software was sent out lists medical facilities, physicans, and SonoSite Distributors.

SonoCalc IMT 3.0, a windows based software used in conjunction with images from high-resolution ultrasound systems (MicroMaxx, TITAN, and SonoSite180PLUS). This software generates a report with the patients intima media thickness (IMT) based on average thickness of the carotid artery.

Serial numbers for the Stand Mounted Assembly (P12822):  03J5RJ; 03J5G2; 03J5RX; 03J5GC; 03J5FN; 03J5RH; 03J5BL; 03J5FF; 03J5D1; 03J5CV; 03J5D0; 03J5GN; 03J4RB; 03J5D4; 03J5G9; 03HPVK; 03J5T3; 03HPVF; 03J4RD; 03J5D3; 03J5G1; 03J5FD; 03J5G5; 03J5CZ; 03J4RC; and 03J4RG.      Serial numbers for the Docking Assembly (P12834):  03J4R0; 03J4R1; 03J5CY; 03J4R4; 03J520; 03J5FK; 03J5G7; 03J5G8; 03J51R; 03J5BF; 03J5BH; 03J4R6; 03J5GJ; 03J5GG; 03J5FL; 3J4RX; 03J5GK; 03J0GR; 03J5RR; 03J5G6; 03J5RC; 03J5FJ; 03J5G5; 03J5RV; 03J5GH; and 03J5RF.

Radiology Devices

2

No

Worldwide Distribution -- USA, including states of GA, NM, PA, TX, VA, and WA and country of Australia.

PowerPark is an accessory to the V or H Universal Stand and comprised of two parts: the stand mounted assembly (P12822) and a docking assembly (P12834). The stand mounted assembly is mounted to the V or H Universal stand and the docking assembly is plugged into a wall circuit. It provides a docking and charging station for the V and H Universal Stands. || The product marketing brochure labeled in part: "SonoSite Ltd...21919 30th Drive SE... Bothell, WA 98021, USA".

38 units are identified with Serial numbers:  0361MW, 036MH5, 0365TR, 036MH3, 0360VT, 036MGZ, 03661X, 035TCZ, 037Y9N, 036MH1, 0365TN, 0360VW, 03661W, 035KXD, 037Y9M, 035KXC, 037Y84, 036MH6, 037Y9L, 0365TX, 03616X, 037Y8D, 037Y83, 0365TW, 035L1M, 036MH8, 035TXC, 0360TN, 0361MQ, 03616Z, 035NTF, 034RZG, 037YKG, 037YKH, 0361CG, 036MH9, 0365TT and 037YKM.

Radiology Devices

2

No

Devices were distributed to medical centers and hospitals in AR, CA, IN, KS, MA, MD, MI, NC, NE, NJ, NV, OH, SC, TN, TX, WI, Washington DC and to FOREIGN COUNTRIES Australia, China, France, Germany, Greece, Hong Kong, India, Iraq, Italy, Korea, Republic of, Libyan Arab Jamahiriya, Mexico, Spain, United Arab Emirates, United Kingdom, and United States.

SLT transducer is used on the SonoSite MicroMaxx ultrasound system. The SLT Transducer label is labeled in part: " MicroMaxx SLT...Manufactured for SonoSite, Inc., Bothell, WA 98021".

16 devices are identified with Serial Numbers:  038VWM, 038FK1, 0379P6, 038G67, 038VWK, 038192, 0379P1, 0379P2, 038FJZ, 038FJW, 0379P0, 0379P5, 037WMJ, 038VWP, 037XT6, and 038153.

Radiology Devices

2

No

Devices were distributed to medical centers and hospitals in AR, CA, IN, KS, MA, MD, MI, NC, NE, NJ, NV, OH, SC, TN, TX, WI, Washington DC and to FOREIGN COUNTRIES Australia, China, France, Germany, Greece, Hong Kong, India, Iraq, Italy, Korea, Republic of, Libyan Arab Jamahiriya, Mexico, Spain, United Arab Emirates, United Kingdom, and United States.

Laparoscopic Ultrasound Transducer (LAP Transducer) is used on the SonoSite MicroMaxx ultrasound system. The LAP Transducer label is labeled in part: "MicroMaxx LAP...Manufactured for SonoSite, Inc., Bothell, WA 98021".

Serial Numbers: 037XT6, 0379P5, 037WMJ, 0379P1, 0379P2, 0379P0 Part Number: P05507-10

Radiology Devices

2

No

Distribution to USA (Tennessee & Ohio), France, Korea, and Germany.

MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer