System, Simulation, Radiation Therapy
Regulation 892.5840
0510(k)s in 12 months (70 all time)
0recalls in 12 months (13 all time)
11recalls that name a 510(k)
Top companies in KPQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens Medical Solutions USA, Inc. | 3 | 9 |
| Varian Assoc., Inc. | 6 | 0 |
| Nucletron Corp. | 5 | 0 |
| Varian Medical Systems, Inc. | 4 | 1 |
| Computerized Medical Systems, Inc. | 3 | 0 |
| Victoreen, Inc. | 3 | 0 |
| GE Healthcare | 1 | 1 |
| Ge Hungary Kft | 2 | 0 |
| GE Medical Systems | 1 | 1 |
| Haynes Radiation Ltd., Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 12, 1987 | K870221 | T.O.P. 2000 (TOMOGRAPHIC ORIENTATED PLANNING) Kermath Mfg. Corp. | KPQ |
| Jan 10, 1986 | K854880 | RADIATION BEAM DATA ACQUISTIOIN SYSTEMS Computerized Medical Systems, Inc. | KPQ |
| Jan 10, 1986 | K853671 | BEAMSCAN Victoreen, Inc. | KPQ |
| Oct 28, 1985 | K853349 | VARIAN XIMATRON C-SERIES RADIOTHERAPY TREATMENT ST Varian Assoc., Inc. | KPQ |
| Oct 28, 1985 | K852410 | MEVAPLAN AND SOMADOS Siemens Medical Solutions USA, Inc. | KPQ |
| Aug 7, 1985 | K851813 | THERPAC-RADIATION THERAPY TREATMENT PLANNING SYSTE Victoreen, Inc. | KPQ |
| Jul 26, 1985 | K850977 | COMPUTE RX-PLAN Medicalibration | KPQ |
| May 23, 1985 | K851653 | VARIAN/XIMATRON 5 CARBON-FIBER COUCH TOP Varian Assoc., Inc. | KPQ |
| Dec 29, 1983 | K834281 | RAD II SIMULATOR Haynes Radiation Ltd., Inc. | KPQ |
| Nov 5, 1981 | K812726 | KERMATH THERAPY SIMULATOR Kermath Mfg. Corp. | KPQ |
| May 13, 1981 | K810858 | XIMATRON V Siemens Corp. | KPQ |
| Jan 22, 1981 | K803124 | SIDOS U. Siemens Corp. | KPQ |
| Jan 22, 1981 | K803032 | PFIZER PZ-SLM RAD. THERAPY TRTMT. SIMUL. Pfizer Medical Systems, Inc. | KPQ |
| Dec 20, 1978 | K782005 | RADIATION ONCOLOGY SYSTEM Adac Laboratories | KPQ |
| Sep 14, 1978 | K781519 | EMI SIMULATOR REMOTE CONTROL CONSOLE Emi Medical, Inc. | KPQ |
| Sep 14, 1978 | K781496 | XIMATRON IV Siemens Elema AB | KPQ |
| Jun 27, 1978 | K780963 | X-RAY SYSTEM General X-Ray, Inc. | KPQ |
| Feb 7, 1977 | K770202 | CTM (CLINAC TREATMENT MONITOR) Varian Assoc., Inc. | KPQ |
| Dec 21, 1976 | K761265 | VARIPLAN COMPUT. RADIOTHERAPY Varian Assoc., Inc. | KPQ |
| Aug 23, 1976 | K760420 | FILTER, VACUUM LINE LINEGUARD Diemolding Corp. | KPQ |
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