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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 20, 2014 | Siemens Medical Solutions USA, Inc Siemens SimView NT and SimView NT with IDI simulation system components:
Product Usage: The intended use of the Radiation Therapy Simulation system is used for simulation of treatment planning prio Terminated |
KPQ | K953233 |
| Jan 17, 2014 | Siemens Medical Solutions USA, Inc SIMVIEW NT and SIMVIEW NT with IDI:
October 01, 2012 Siemens ceased Simview distribution.
Manufactured by:
Mecaserto now known as Mecasim
Parc de lEsplanade
9,Rue Niels Bohr
77400 Saint Thibault de Terminated |
KPQ | K953233 |
| Jan 30, 2013 | GE Healthcare, LLC AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5, 5160092-4 version 7.6. Terminated |
KPQ | K052345 |
| Aug 17, 2009 | GE Medical Systems, LLC AdvantageSim MD versions 7.4 through 7.6, Model 5160092.
AdvantageSim MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosime Terminated |
KPQ | K052345 |
| Jan 13, 2009 | Siemens Medical Solutions USA, Inc Drive Belt for Radiation Therapy Simulation systems SIMVIEW 3000 and SIMVIEW NT with CT option or IDI.
Radiation therapy simulation system. Terminated |
KPQ | K946053 K953233 |
| Jul 30, 2008 | Varian Medical Systems Oncology Systems Acuity with Conebeam Computed Tomography; Radiation therapy simulation system; Model Number: H77. Terminated |
KPQ | K033339 |
| Jun 28, 2008 | Siemens Medical Solutions USA, Inc Update Instructions "TH003/08/S" applies to Siemens brand SIMIVIEW 3000, SIMVIEW NT, and MEV ASIM S systems;
Part Number: 5488460; Product is manufactured and distributed by
Siemens Medical Solutions Terminated |
KPQ | K946053 K953233 |
| Jan 31, 2008 | Siemens Medical Solutions USA, Inc Si emans Evansi, with patient table, Part No: 44 81 586, and without patient table Part No: 44-81-669; Siemens Medical Solutions USA, Concord, CA 94520 Terminated |
KPQ | None listed |
| Jan 31, 2008 | Siemens Medical Solutions USA, Inc Si emans Simview NT Cassette Holder Electronic Imaging Device (Image Identifier) with IDI, Part No: 54 97 016; Siemens Medical Solutions USA, Concord, CA 94520 Terminated |
KPQ | K946053 |
| Jan 31, 2008 | Siemens Medical Solutions USA, Inc Si emans Simview NT Cassette Holder Electronic Imaging Device (Image Identifier) with CT, Part No: 54 96 984; Siemens Medical Solutions USA, Concord, CA 94520 Terminated |
KPQ | K946053 |
| Jan 31, 2008 | Siemens Medical Solutions USA, Inc Si emans Simiae NT Cassette Holder Electronic Imaging Device (Image Identifier) Part No. 54 96 992 ;Siemens Medical Solutions USA, Concord, CA 94520 Terminated |
KPQ | None listed |
| Jan 31, 2008 | Siemens Medical Solutions USA, Inc Si emans Simiae 3000 Cassette Holder Electronic Imaging device (Image Identifier), with CT Part No: 19 57-161 or without CT Part No. 19 57 153; Siemens Medical Solutions USA, Concord, CA 94520 Terminated |
KPQ | K946053 |
| Nov 8, 2007 | Varian Medical Systems Inc Ximatron Digital Imaging (Ximavision), V 7.5.51 with Service Pack (SP), Oncology Information System, Varian Medical Systems Terminated |
KPQ | K851653 |
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