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CODES: All codes from H480005 through H48C896

Radiology Devices

2

No

Worldwide Distribution.

Varian brand Eclipse Release 10 with RT Chart Release 10 (Client Build 10.0.28 or Build 10.0.34), An || Eclipse Treatment Planning System used with ARIA Radiation Oncology (RT Chart || module), Reference/FSCA Identifier: CP-05277, Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. || The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.

141 units are identified as Site Numbers:  205580, 214178, 204898, 215014, 238042, 223106, 204913, 218202, 546102, 204320, 203515, 205771, 223029, 220012, 238223, 217489, 238200, 209637, 205582, 205773, 238151, 547644, 205699, 204140, 549386, 223236, 550477, 204128, 74269, 238135, 238087, 209689, 238082, 238198, 223003, 209535, 218105, 220033, 204912, 209721, 238019, 205720, 42635610, 223036, 205772, 238093, 238055, 209874, 218077, 220039, 223303, 218218, 212824, 225131, 209288, 238224, 212802, 238096, 215016, 223030, 238043, 209666, 238023, 238013, 203583, 209555, 218203, 218122, 218123, 209536, 203514, 218073, 214398, 204934, 209571, 238209, 212816, 223341, 209572, 218035, 203034, 205700, 203069, 223019, 238010, 548641, 220031, 205577, 223921, 238214, 204318, 209538, 225019, 238086, 540928, 220013, 203510, 203511, 204933, 238014, 218107, 209660, 212863, 218104, 223144, 225073, 218078, 203127, 223146, 207460, 205774, 203036, 238015, 245524, 212943, 214511, 205557, 223021, 204162, 204907, 217494, 238027, 542738, 205554, 220026, 220014, 223027, 225188, 238092, 238227, 238165, 209684, 238046, 223024, 238091, 223737, 220001, 223039, 204917, 204930, and 223237.

Radiology Devices

2

No

Nationwide Distribution: USA., including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY. There is no distribution to foreign consignees.

Eclipse, Nuclear Magnetic Resonance Imaging system, Magnet Subsystem, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143, U.S.A.".

Eclipse version 11 and 13

Eclipse Treatment Planning System