calendar
18,427 catalysts · 4,728 grant · 3,292 8k filing · 2,639 approval · 2,188 device 510k · 1,786 device recall · 1,536 device pma
18,427 catalysts · 4,728 grant · 3,292 8k filing · 2,639 approval · 2,188 device 510k · 1,786 device recall · 1,536 device pma
Millenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging — Reason: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. — Status: Ongoing
Starcam/Camstar; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging — Reason: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. — Status: Ongoing
Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging — Reason: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. — Status: Ongoing
Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging — Reason: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. — Status: Ongoing
Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging — Reason: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. — Status: Ongoing
Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging — Reason: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. — Status: Ongoing
Millenium MPS; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging — Reason: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. — Status: Ongoing
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 780 MD, Rx Only — Reason: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. — Status: Ongoing
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Panorama 35 MD, Rx Only — Reason: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. — Status: Ongoing
Elscint Cardial; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging — Reason: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. — Status: Ongoing
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 530 MD, Rx Only — Reason: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. — Status: Ongoing
Maxicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging — Reason: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. — Status: Ongoing
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uEXPLORER MD, Rx Only — Reason: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement. — Status: Ongoing
Cardiac Workstation 7000; Model Number: 860441; — Reason: Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short. — Status: Ongoing
Optima NX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging — Reason: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. — Status: Ongoing
CA grant. $2,746,080. PI: MICHAEL Howard ANTONI
AI grant. $3,554,273. PI: Yunda Huang
HL grant. $2,177,784. PI: Jiyoung Ahn
MD grant. $3,158,761. PI: Joshuaa Dominic Allison-Burbank
HD grant. $5,908,975. PI: PAIGE L WILLIAMS
HL grant. $461,115. PI: Robert Paul Thomen
GM grant. $368,367. PI: Joseph F Cotten
HL grant. $811,885. PI: Michael Alexanian
MH grant. $313,800. PI: Gabriela Asturias
MH grant. $449,958. PI: Joseph McGuire
HD grant. $1,588,500. PI: Min Yang
AG grant. $126,404. PI: Anoop Jain
ES grant. $523,875. PI: Julia Yue Cui
NS grant. $5,057,591. PI: Macarius M. Donneyong
CA grant. $10,000. PI: Shannon Marie Lauberth
DK grant. $3,162,826. PI: Andrew Scott Little
GM grant. $261,620. PI: Gauri Agarwal
HD grant. $677,535. PI: Debra Lynne Herbenick
GM grant. $437,446. PI: Can Emre Senkal
NS grant. $3,081,936. PI: Bogdan Bintu
AI grant. $3,047,991. PI: Michael G. Brown
HL grant. $651,009. PI: Long-Sheng Song
AA grant. $647,330. PI: Rita P Cervera Juanes
AI grant. $140,740. PI: Omar Harfouch
ES grant. $645,113. PI: Julia Yue Cui
HL grant. $81,040. PI: Jay Aaron Bowman-Kirigin
CA grant. $499,990
AI grant. $200,824. PI: Philip Andrew Chan
MH grant. $729,286. PI: Elizabeth Anne BUKUSI
DK grant. $305,844. PI: MARTIN R PRINCE
HD grant. $804,807. PI: Elizabeth Topper
EB grant. $349,481. PI: Ehsan Samei
DK grant. $931,500. PI: Ana Francisca Diallo
CA grant. $935,075. PI: Boyu Hu
HD grant. $636,544. PI: Arianna Rubin Means