Invivo Corporation

Model No. 866120; Lot/ Serial Numbers: US33600065, US33600066, US33600075, US33600077, US33600078, US33600079; US33600080, US33600081, US33600082, US33600083, US33600084, US33600086, US33600087, US33600088, US33600089, US33600090, US33600091, US33600092, US33600093, US33600094.

Cardiovascular Devices

2

No

CA, FL, IN, KY, MN, NC, NJ, NY, OK, SD and TX Netherlands, Poland and United Kingdom.

Philips Expression MR200 MRI Patient Monitoring System.

Model 866120 with the following lots #'s: US33600006, US33600007, US33600011, US33600012 and US33600013

Cardiovascular Devices

2

No

Worldwide Distribution: US distribution in state of: CA and countries of: Poland, Singapore, and Sweden.

Philips Expression MR200 MRI Patient Monitoring System Model 866120

Model: 866120, Lot numbers: US33600004, US33600005, US33600006, US33600007, US33600008, US33600009, US33600010, US33600011, US33600012, US33600013, US33600014, US33600015, US33600016, US33600017, US33600018, US33600019, US33600020, US33600022, US33600023, US33600024, US33600025, US33600026, US33600027, US33600028.

Cardiovascular Devices

2

No

Worldwide Distribution - US including the states of CA, GA, MI, NJ, NV, and TX., and the countries of: Austria, Finland, Germany, Poland, Singapore, Sweden, Switzerland and United Kingdom.

Philips Expression MR200 MRI Patient Monitoring System

US23200113, US23200120, US23200121, US23200122, US23200123, US23200124, US23200125, US23200126, US23200127, US23200128, US23200129, US23200130, US23200131, US23200132, US23200133, US23200134, US23200135, US23200136, US23200137, US23200138, US23200139, US23200140, US23200141, US23200142, US23200143, US23200144, US23200145, US23200146, US23200147, US23200148, US23200149, US23200150, US23200151, US23200152, US23200153, US23200154, US23200155, US23200156, US23200157, US23200158, US23200159, US23200160, US23200161, US23200162, US23200163, US23200164, US23200165, US23200166, US23200167, US23200168, US23200169, US23200170, US23200172, US23200173, US23200176, US23200177, US23200178, US23200179, US23200180, US23200181, US23200182, US23200183, US23200184, US23200185, US23200186, US23200187, US23200188, US23200189, US23200190, US23200191, US23200192, US23200193, US23200194, US23200195, US23200196, US23200197, US23200198, US23200199, US23200200, US23200201, US23200202, US23200203, US23200204, US23200205, US23200206, US23200207, US23200208, US23200209, US23200210, US23200211, US23200212, US23200213, US23200214, US23200215, US23200216, US23200217, US23200218, US23200219, US23200220, US23200221, US23200222, US23200223, US23200224, US23200225, US23200226, US23200227, US23200228, US23200229, US23200230, US23200231, US23200232, US23200233, US23200234, US23200235, US23200236, US23200237, US23200238, US23200239, US23200240, US23200241, US23200242, US23200243, US23200244, US23200245, US23200246, US23200247, US23200248, US23200249, US23200250, US23200251, US23200252, US23200253, US23200254, US23200255, US23200256, US23200258, US23200259, US23200260, US23200261, US23200262, US23200263, US23200264, US23200265, US23200266, US23200267, US23200268, US23200269, US23200270, US23200271, US23200272, US23200273, US23200274, US23200275, US23200276, US23200277, US23200278, US23200279, US23200280, US23200281, US23200282, US23200283, US23200284, US23200285, US23200286, US23200287, US23200288, US23200289, US23200290, US23200291, US23200292, US23200293, US23200294, US23200295, US23200296, US23200297, US23200298, US23200299, US23200300, US23200301, US23200302, US23200303, US23200304, US23200305, US23200306, US23200307, US23200308, US23200309, US23200310, US23200311, US23200312, US23200313, US23200314, US23200315, US23200316, US23200317, US23200318, US23200319, US23200320, US23200321, US23200322, US23200323, US23200324, US23200325, US23200326, US23200327, US23200328, US23200329, US23200330, US23200331, US23200332, US23200333, US23200334, US23200335, US23200336, US23200337, US23200338, US23200339, US23200340, US23200341, US23200342, US23200343, US23200344, US23200345, US23200346, US23200347, US23200349, US23200350, US23200351, US23200352, US23200353, US23200354, US23200355, US23200356, US23200357, US23200358, US23200359, US23200360, US23200361, US23200362, US23200363, US23200364, US23200365, US23200366, US23200367, US23200368, US23200369, US23200370, US23200371, US23200372, US23200373, US23200374, US23200375, US23200376, US23200377, US23200378, US23200379, US23200380, US23200381, US23200382, US23200383, US23200385, US23200386, US23200387, US23200388, US23200389, US23200390, US23200391, US23200393, US23200394, US23200395, US23200397, US23200398, US23200399, US23200400, US23200401, US23200402, US23200403, US23200405, US23200406, US23200407, US23200408, US23200410, US23200411, US23200413, US23200414, US23200415, US23200416, US23200417, US23200419, US23200421, US23200422, US23200423, US23200424, US23200425, US23200427, US23200428, US23200429, US23200431, US23200434

Cardiovascular Devices

2

No

Worldwide Distribution - USA and the countries of Australia, Austria, Denmark, France, Germany, Netherlands, Poland, Singapore, Sweden, Switzerland, United Kingdom.

Invivo Corporation Expression IP5 Information Portal || Product Usage: || The Expression Information Portal (Model IP5) a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professional to remotely monitor the vital signs of patients undergoing MRI procedures. Available monitoring from the IP5 can include ECG, SpO2, non-invasive and invasive blood pressure, CO2, respiration, anesthetic agents, gases, and temperature parameters.

Model number 865214: (Service Numbers 453564180091, 453564181201). Lot numbers: US00201487, US00201488, US00201489, US00201490, US00201493, US11401510, US11401511, US11401513, US11401514, US11401515, US11401516, US11401531, US11401532, US11401533, US11401546, US11401562, US11401563, US11401564, US11401565, US11401566, US11401567, US11401568, US11401569, US11401570, US11401571, US11401572, US11401573, US11401574, US11401575, US11401576, US11401577, US11401578, US11401579, US11401611, US11401617, US11401618, US11401631, US11401633, US11401634, US11401645, US11401646, US11401647, US11401648, US11401649, US11401651, US11401652, US11401672, US11401673, US11401674, US11401675, US11401712, US11401713, US11401714, US11401715, US11401716, US11401717, US11401718, US11401719, US11401720, US11401721, US11401722, US11401723, US11401724, US11401737, US11401738, US11401739, US11401740, US11401741, US11401742, US11401743, US11401744, US11401745, US11401746, US11401747, US11401775, US11401776, US11401777, US11401778, US11401779, US11401780, US11401781, US11401782, US11401783, US11401784, US11401785, US11401786, US11401799, US11401843, US11401844, US11401845, US11401846, US11401851, US11401871, US11401872, US11401882, US11401883, US11401884, US11401885, US11401886, US11401892, US11401893, US11401903, US11401904, US11401905, US11401916, US11401917, US11401918, US11401969, US11401970, US11401971, US11401972, US11401973, US11401974, US11401975, US13301988, US13301989, US13301990, US13301991, US13301992, US13301993, US13301994, US13301995, US13301996, US13301997, US13301998, US13302000, US13302001, US13302034, US13302035, US13302036, US13302037, US13302039, US13302040, US13302041, US13302042, US13302043, US13302044, US13302050, US13302051, US13302052, US13302054, US13302055, US13302094, US13302095, US13302096, US13302097, US13302098, US13302099, US13302107, US13302108, US13302109, US13302111, US13302112, US13302113, US13302114, US13302115, US13302117, US13302118, US13302119, US13302141, US13302148, US13302175, US13302176, US13302177, US13302178, US13302179, US13302180, US13302182, US13302192, US13302193, US13302194, US13302195, US13302196, US13302197, US13302198, US13302209, US13302210, US13302211, US13302212, US13302247, US13302248, US13302249, US13302250, US13302251, US13302252, US13302254, US13302265, US13302266, US13302267, US13302291, US13302292, US13302293, US13302294, US13302295, US13302296, US13302297, US13302298, US13302300, US13302302, US13302304, US13302346, US13302347, US13302348, US13302349, US13302350, US13302362, US13302363, US13302364, US13302365, US13302366, US13302367, US13302373, US13302378, US13302421, US13302422, US13302423, US13302424, US13302425, US13302427, US13302430, US13302431, US13302432, US13302434, US13302437, US13302438, US13302439, US13302441, US13302445, US13302446, US13302447, US13302449, US13302450, US13302478, US13302485, US13302488, US13302498, US13302501, US13302503, US13302504, US13302505, US13302507, US13302508, US13302509, US13302510, US13302511, US13302512, US13302513, US13302514, US13302515, US13302516, US13302517, US13302519, US13302520, US13302521, US13302522, US13302523, US13302524, US13302525, US13302526, US13302527, US13302528, US13302529, US13302609, US13302610, US13302612, US13302613, US13302614, US13302617, US13302618, US13302619, US13302620, US13302621, US13302622, US13302623, US13302624, US13302625, US13302631, US13302641, US13302642, US13302644, US13302645, US13302646, US13302647, US13302648, US13302649, US13302650, US13302651, US13302652, US13302653, US13302654, US13302656, US13302657, US13302658, US13302701, US13302702, US13302703, US13302704, US13302705, US13302706, US13302708, US13302709, US13302710, US13302713, US13302714, US13302715, US13302716, US13302717, US13302782, US13302783, US13302784, US13302785, US13302786, US13302787, US13302788, US13302789, US13302790, US13302804, US13302805, US13302806, US13302807, US13302808, US13302809, US13302810, US13302811, US13302812, US13302837, US13302852, US13302853, US13302854, US13302855, US13302856, US13302864, US13302865, US13302866, US13302871, US13302872, US13302873, US13302874, US13302875, US13302878, US13302879, US13302880, US13302881, US13302882, US13302883, US13302887, US13302888, US13302914, US13302915, US13302937, US13302938, US13302939, US13302940, US13302941, US13302942, US13302943, US13302944, US13302954, US13302955, US13302956, US13302957, US13302958, US13302959, US13302960, US13302982, US13302983, US13302985, US13302986, US13302987, US13302988, US13302989, US13302990, US13302991, US13302992, US13302993, US13302998, US13302999, US13303000, US13303001, US13303002, US13303048, US13303049, US13303050, US13303051, US13303052, US13303053, US13303054, US13303055, US13303056, US13303057, US13303080, US13303084, US13303085, US13303086, US13303126, US13303127, US13303128, US13303129, US13303130, US13303158, US13303159, US13303160, US13303161, US13303162, US13303163, US13303178, US13303179, US13303180, US13303187, US13303188, US13303203, US13303214, US13303216, US13303217, US13303219, US13303221, US13303222, US13303223, US13303224, US13303238, US13303239, US13303240, US13303241, US13303243, US13303244, US13303245, US13303270, US13303271, US13303272, US13303273, US13303288, US13303298, US13303306, US13303325, US13303326, US13303327, US13303328, US13303329, US13303330, US13303331, US13303332, US13303333, US13303334, US13303347, US13303348, US13303349, US13303350, US13303351, US13303352, US13303380, US13303381, US13303382, US13303383, US13303384, US13303387, US13303388, US13303409, US13303413, US13303414, US13303416, US13303417, US13303418, US13303419, US13303420, US13303421, US13303422, US13303436, US13303462, US13303463, US13303464, US13303465, US13303466, US13303467, US13303468, US13303482, US13303488, US13303489, US13303490, US13303499, US13303500, US13303501, US13303502, US13303503, US13303504, US13303505, US13303506, US13303507, US13303508, US13303509, US13303510, US13303511, US13303512, US13303543, US13303544, US13303573, US13303574, US13303575, US13303576, US13303577, US13303578, US13303579, US13303580, US13303584, US13303585, US13303586, US13303587, US13303588, US13303589, US13303590, US13303591, US13303597, US13303598, US13303601, US13303625, US13303626, US13303627, US13303628, US13303630, US13303631, US13303662, US13303665, US13303666, US13303667, US13303668, US13303671, US13303672, US13303721, US13303722, US13303723, US13303724, US13303725, US13303726, US13303727, US13303733, US13303734, US13303735, US13303738, US13303739, US13303748, US13303749, US13303750, US13303780, US13303781

Cardiovascular Devices

2

No

Worldwide Distribution-USA (nationwide) including the states of MO; MS; MA; IL; OH; NY; KS; PA; WI; VA; SD; AZ; FL; OR; TX; MA; MO; FL; MA; MI; CT; CA; NJ; NC; ME; IL; MA; MA; WV; MA; MN; CA; AL; AL; WI; DC; OH; WV; CA; NC; NY; MT; NJ; CA; WA; IN; MI; PA; TX; NC; TN; TX; ID; NM; IL; PA; IN; IL; WA; CO; MN; CA; IN; MD; MI; DC; GA; DE; CO; CT; WA; NJ; MD; TX; TN; MN; WA; CA; FL; OH; PA; NY; IN; OK; ID; IA; NY; WI; VA; CA; HI; MS; TX; HI; CT; TN; OR; WA; PA; NH; CA; MA; LA; IN; PA; AZ; GA; UT; ND; GA; TX; TX; IN; CA; MI; CT; CA; NC; MS; VA; IN; MI; NE; NV; MI; WA; IL; KY; LA; OR; OK; LA; TN; KY; TX; CA; PA; NM; NC; CO; DC; AL; MI; TX; SD; PA; OR; ID; NM; SD; CO; MN; NJ; MI; ND; MN; MT; LA; CT; WA; TX; IA; NJ; WI; SD; and UT, and the countries of Canada, Italy, Thailand, Russian Federation, Saudi Arabia, Slovenia, Singapore, Republic of Korea, Uzbekistan, Iceland, Israel, Austria, United Kingdom, Afganhistan, Japan, South Africa, Germany, Qatar, Netherlands, Switzerland, Denmark, and Sweden.

Invivo Corporation Expression MRI Patient Monitoring System. || The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for synchronization to the MR scanner.