Modulex RTP System
FDA 510(k) K913017 · Computerized Medical Systems, Inc.
510(k) numberK913017
Submission
- Device name
- Modulex RTP System
- Applicant
- Computerized Medical Systems, Inc.
Maryland Heights, MO, US - Received
- July 9, 1991
- Decision date
- October 17, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Nucletron Corporation
| 510(k) | Device | Decision |
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| K110730 | Monaco RTP SystemMUJ · Traditional | 06/24/2011SE |
| K102216 | Xio RTP SystemMUJ · Traditional | 10/01/2010SE |
| K092132 | Xio RTP SystemMUJ · Traditional | 09/24/2009SE |
| K091179 | Monaco RTP System, Vmat OptionMUJ · Traditional | 07/16/2009SE |
| K080799 | Atlas-Based AutosegmentationLHN · Traditional | 08/07/2008SE |
| K071938 | Monaco RTP SystemMUJ · Traditional | 10/01/2007SE |
| K032762 | Xio Radiation Treatment Planning SystemIYE · Traditional | 12/02/2003SE |
| K032100 | I-BeamIYE · Traditional | 10/02/2003SE |
| K020027 | Focus Radiation Treatment Planning SystemMUJ · Traditional | 10/08/2002SE |
| K013112 | Focal SimMUJ · Traditional | 12/05/2001SE |
Questions and answers
When was Modulex RTP System cleared by the FDA?
Modulex RTP System (K913017) received a 510(k) decision of Substantially Equivalent on October 17, 1991, 100 days after the submission was received.
What is the product code of K913017?
The FDA product code is KPQ – System, Simulation, Radiation Therapy, a Class II (moderate risk) device regulated under 21 CFR 892.5840.