Signa Ovation Medical Systems

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GE Medical Systems - Food and Drug Administration

https://www.accessdata.fda.gov/cdrh_docs/pdf2/k023442.pdf

The Signa Ovation (formerly known as MFO/I) system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The …

MRI - Signa Ovation™ - MR-TIP: Database

https://www.mr-tip.com/serv1.php?type=db1&gid=942

the Signa Ovation ™ is a patient-friendly open MRI scanner designed not only to handle a typical patient mix, but to accommodate larger patients, patients who are claustrophobic, …

Class 2 Device Recall GE Healthcare Signa Ovation 0.35T

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=79750

Product. GE Healthcare Signa Ovation 0.35T, Model Numbers: Ovation 1-3 (2276937), Ovation 4 (2377062-2, 2377062-5, 2377062-8, or 5118172), and Ovation 5 (5148725). …

510(k) Premarket Notification

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?start_search=1&ProductCode=&KNumber=&Applicant=GE%20MEDICAL%20SYSTEMS&DeviceName=SIGNA&Type=&ClinicalTrials=&DecisionDateTo=09%2F09%2F2014&Redact510K=&CombinationProducts=&ZNumber=&sortcolumn=an_asc

3.0.t signa vh/i (t/r) body imaging coil: GE MEDICAL SYSTEMS K003613: 04/03/2001 ge 0.35t signa ovation with excite mr system: GE MEDICAL SYSTEMS K053009: …

Class 2 Device Recall GE Signa Ovation 0.35 T MR System

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=81910

The Signa Ovation System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. Code Information Model Numbers: …

Medical Device Recalls

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=201&event_id=&productdescriptiontxt=gna&productcode=&rootCauseText=¢erclassificationtypetext=&recallnumber=&postdatefrom=&postdateto=12%2F01%2F2014&productshortreasontxt=&firmlegalnam=&PMA_510K_Num=&pnumber=&knumber=&sortcolumn=lnd

GE Medical Systems, LLC Signa Openspeed 0.7T MR Systems, Model Numbers: Openspeed 3 (2138300-30), Openspeed 4 (2377062-5),... 2 08/25/2009 GE Medical …

Medical Device Recalls

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&event_id=51314&productcode=&rootCauseText=&postdatefrom=&postdateto=&PMA_510K_Num=&sortcolumn=cca

GE Medical Systems, LLC Z-1722-2009 - GE Healthcare Signa Ovation 0.35T, Model Numbers: Ovation 1-3 (2276937), Ovation 4 (2377062-2, 2377062-5, 2377062-8, or …

International Medical Devices Database

https://es.medicaldevices.icij.org/events/usa-device-recall-ge-healthcare-signa-ovation-0-35t

The 0.35T Signa Ovation with Excite Magnetic Resonance system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of …

Device Recall GE Healthcare Signa Ovation 0.35T 의 리콜

https://ko.medicaldevices.icij.org/events/usa-device-recall-ge-healthcare-signa-ovation-0-35t

The letter described the Safety Issue, Affected Product, Safety Instructions, Product Correction and Contact Information for the Signa Ovation 0.35T Systems. A second GE …

GE Signa Ovation 0.35 T MR System 의 리콜

https://ko.medicaldevices.icij.org/events/usa-ge-signa-ovation-0-35-t-mr-system

Ge healthcare has identified a potential safety issue with the signa openspeed and signa ovation mr scanner tables that may impact patient safety. the table may begin lowering …

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GE Medical Systems - Food and Drug Administration

MRI - Signa Ovation™ - MR-TIP: Database

Class 2 Device Recall GE Healthcare Signa Ovation 0.35T

510(k) Premarket Notification

Class 2 Device Recall GE Signa Ovation 0.35 T MR System

Medical Device Recalls

Medical Device Recalls

International Medical Devices Database

Device Recall GE Healthcare Signa Ovation 0.35T 의 리콜

GE Signa Ovation 0.35 T MR System 의 리콜

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