Advantage Sim MD
FDA 510(k) K052345 · GE Healthcare
510(k) numberK052345
Submission
- Device name
- Advantage Sim MD
- Applicant
- GE Healthcare
Waukesha, WI, US - Received
- August 26, 2005
- Decision date
- September 14, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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| K072445 | Integrated Brachytherapy Unit - DigitalKPQ · Special | Nucletron Corp. | 09/14/2007SE |
| K061006 | IkoengeloKPQ · Traditional | Ikoetech, LLC | 06/05/2006SE |
| K052361 | Simulix-Evolution with Oncentra ConebeamKPQ · Special | Nucletron Corporation | 10/24/2005SE |
| K033470 | Simulix EvolutionKPQ · Special | Nucletron Corporation | 02/04/2004SE |
| K033339 | Acuity with Conebeam Computed TomographyKPQ · Traditional | Varian Medical Systems, Inc. | 12/30/2003SE |
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Questions and answers
When was Advantage Sim MD cleared by the FDA?
Advantage Sim MD (K052345) received a 510(k) decision of Substantially Equivalent on September 14, 2005, 19 days after the submission was received.
What is the product code of K052345?
The FDA product code is KPQ – System, Simulation, Radiation Therapy, a Class II (moderate risk) device regulated under 21 CFR 892.5840.