Ingenuity CT

Model #728326, 510(k) #KK033326, Serial Numbers: 300010 and 300018.

Radiology Devices

2

No

Worldwide Distribution - USA including Ohio and the countries of Australia, China, Belgium, Israel, and Sweden

Ingenuity CT computed Tomography System, Model #728326, 510(k) #K 033326, Serial Numbers: 300010 and 300018. || The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

Model #'s - Brilliance 64: 728231, Ingenuity CT: 728326, iCT: 728306; iCT SP: 728311 & Brilliance Big Bore: 728243

Radiology Devices

2

No

Worldwide Distribution -- USA, including the states of: AL, AZ, CA, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NM, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA & WV and the countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BANGLADESH, BELGIUM, Brazil, CHINA, COLUMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KOREA, LUXEMBOURG, MALAYSIA, MALI, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PHILIPPINES, POLAND, QATAR, RUSSIA, SINGAPORE, SLOVENIA, SOUTH KOREA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, THAILAND, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN & VIETNAM.

Computed Tomography X-Ray Systems (Brilliance 64, Model Number: 728231; Brilliance Big Bore, Model Number: 728243; Brilliance iCT, Model Number: 728306; Brilliance iCT SP, Model Number: 728311; and Ingenuity CT, Model Number: 728326); Mfr. by Philips Medical Systems; Cleveland, OH. || Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

91003, 30018, 95504, 300004, 300030, 300010, 95130, 95157

Radiology Devices

2

No

Worldwide Distribution: US distribution in OH and countries of: Australia, China, Belgium, Israel, and Sweden.

The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

Model No. 728326; S/N: 2, 1234, 30005, 30009, 30017, 30018, 30020, 30023, 30028, 30031, 30034, 30037, 31001, 32065, 32067, 52030, 52031, 52044, 52049, 52050, 300159, 300204, 300205, 300207, 300208, 300209, 310002, 310003, 333057, 333064 & 336061.

Radiology Devices

2

No

Worldwide distribution. US nationwide, Australia, Austria, Bangladesh, Belgium, Brazil, Cambodia, Canada, China, Egypt, France, Germany, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Korea, Lebanon, Libya, Lithuania, Malaysia, Martinique, Myanmar, Mexico, Mozambique, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.

Ingenuity CT Computed Tomography X-ray system