Helax-Imcon, Version 1.0
FDA 510(k) K982857 · Helax AB
510(k) numberK982857
Submission
- Device name
- Helax-Imcon, Version 1.0
- Applicant
- Helax AB
Uppsala, SE - Received
- August 13, 1998
- Decision date
- November 4, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K061006 | IkoengeloKPQ · Traditional | Ikoetech, LLC | 06/05/2006SE |
| K052361 | Simulix-Evolution with Oncentra ConebeamKPQ · Special | Nucletron Corporation | 10/24/2005SE |
| K052345 | Advantage Sim MDKPQ · Traditional | GE Healthcare | 09/14/2005SE |
| K033470 | Simulix EvolutionKPQ · Special | Nucletron Corporation | 02/04/2004SE |
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Questions and answers
When was Helax-Imcon, Version 1.0 cleared by the FDA?
Helax-Imcon, Version 1.0 (K982857) received a 510(k) decision of Substantially Equivalent on November 4, 1998, 83 days after the submission was received.
What is the product code of K982857?
The FDA product code is KPQ – System, Simulation, Radiation Therapy, a Class II (moderate risk) device regulated under 21 CFR 892.5840.