IYCClass II
Generator, Orthovoltage, Therapeutic X-ray
Radiology · 21 CFR 892.5900
MDR events6All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances0All time
Recent MDR events
6 adverse event reports on file
- GYRUS, PK-SP GENERATORAug 4, 2022MalfunctionGyrus Acmi, Inc.3003790304-2022-00149
- GYRUS, PK-SP GENERATORAug 4, 2022MalfunctionGyrus Acmi, Inc.3003790304-2022-00150
- AXXENT ELECTRONIC BRACHYTHERAPY SYSTEMMay 1, 2017MalfunctionXoft, A Subsidary Of Icad, Inc.3005594788-2017-00001
- AXXENT ELECTRONIC BRACHYTHERAPY SYSTEMAug 17, 2016MalfunctionXoft, A Subsidary Of Icad3005594788-2016-00002
- COLLIMATOR ACCESSORY LATCHOct 21, 1996Mitsubishi Intl Corp.MW1010122
- SIEMENSJul 29, 1994InjurySiemens Medical Systems9060
Event type breakdown
Malfunction4
Unspecified1
Injury1
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.