Shadowform
FDA 510(k) K964972 · I.Z.I. Medical Products Corp.
510(k) numberK964972
Submission
- Device name
- Shadowform
- Applicant
- I.Z.I. Medical Products Corp.
Owings Mills, MD, US - Received
- December 12, 1996
- Decision date
- May 5, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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 |
| 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 Shadowform cleared by the FDA?
Shadowform (K964972) received a 510(k) decision of Substantially Equivalent on May 5, 1997, 144 days after the submission was received.
What is the product code of K964972?
The FDA product code is KPQ – System, Simulation, Radiation Therapy, a Class II (moderate risk) device regulated under 21 CFR 892.5840.