Aktina Medical Physics Corporation Tennis Racquet Insert
FDA 510(k) K993522 · Aktina Medical Physics Corp.
510(k) numberK993522
Submission
- Device name
- Aktina Medical Physics Corporation Tennis Racquet Insert
- Applicant
- Aktina Medical Physics Corp.
Congers, NY, US - Received
- October 18, 1999
- Decision date
- January 10, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code JAI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231612 | Eve Patient Positioner SystemJAI · Traditional | Leo Cancer Care | 05/07/2024SE |
| K182683 | Z-Robot Patient Positioning SystemJAI · Traditional | Chinan Biomedical Technology, Inc. | 06/27/2019SE |
| K170502 | Patient Positioning SystemJAI · Special | Forte Automation Systems, Inc. | 04/13/2017SE |
| K160518 | LEONI ORION SystemJAI · Traditional | Leoni Cia Cable System | 07/14/2016SE |
| K132084 | Protura Couch SoftwareJAI · Traditional | Med-Tec, Inc. D/B/A Civco Medical Solutions | 09/26/2013SE |
| K122413 | Patient Positioning SystemJAI · Traditional | Forte Automation Systems, Inc. | 09/13/2012SE |
| K122201 | Protura Couch SoftwareJAI · Traditional | Med-Tec, Inc. D/B/A Civco Medical Solutions | 08/30/2012SE |
| K120520 | Exactrac Robotics Novalis RoboticsJAI · Traditional | Brainlab AG | 06/29/2012SE |
| K120916 | Qfix Radiotherapy ChairJAI · Traditional | Wfr/Aquaplast Corp. | 06/20/2012SE |
| K072898 | Hexapod Evo RT Couch TopJAI · Special | Medical Intelligence Medizintechnik GmbH | 10/25/2007SE |
More from Medical Intelligence Medizintechnik GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K103616 | Pinpoint Stereotactic Head and Neck LocalizerIYE · Traditional | 01/25/2011SE |
| K081935 | Stereotactic Head and Neck Localizer, Model 50-100IYE · Traditional | 10/07/2008SE |
| K040709 | Protos SoftwareIYE · Traditional | 04/28/2004SE |
| K032248 | Precise Carbon Fiber Table Top, Model 11-999IYE · Traditional | 09/25/2003SE |
| K014081 | Aktina Medical Physics Radiation Therapy WedgesIYE · Traditional | 03/05/2002SE |
| K003330 | Aktina Medical Physics Corporation Active Breathing Coordinator (Abc)IYE · Traditional | 01/04/2001SE |
| K991546 | Aktina Medical Physics Corporation Tilt BoardIYE · Traditional | 07/30/1999SE |
| K990997 | Aktina Medicalphysics Corporation Mechanical FrontpointerIYE · Traditional | 06/22/1999SE |
| K974239 | Aktina Medical Physics Corporation Photon Beam Blocking SystemIXI · Traditional | 02/10/1998SE |
| K973953 | Aktina Medical Physics Corporation Eectron Beam Field Shaping SystemIXI · Traditional | 01/14/1998SE |
Questions and answers
When was Aktina Medical Physics Corporation Tennis Racquet Insert cleared by the FDA?
Aktina Medical Physics Corporation Tennis Racquet Insert (K993522) received a 510(k) decision of Substantially Equivalent on January 10, 2000, 84 days after the submission was received.
What is the product code of K993522?
The FDA product code is JAI – Couch, Radiation Therapy, Powered, a Class II (moderate risk) device regulated under 21 CFR 892.5770.