Microselectron-Hdr (High Dose Rate)
FDA 510(k) K864210 · Nucletron-Oldelft Corp.
510(k) numberK864210
Submission
- Device name
- Microselectron-Hdr (High Dose Rate)
- Applicant
- Nucletron-Oldelft Corp.
Columbia, MD, US - Received
- October 28, 1986
- Decision date
- November 26, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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More from Braxx Biotech Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K953946 | Microselectron-Hdr Version 2JAQ · Traditional | 08/13/1996SE |
| K953831 | N 800 HFIZO · Traditional | 09/08/1995SE |
| K925956 | Microselectron - HDR for Mobile EnvironmentJAQ · Traditional | 11/19/1993SE |
| K926407 | Model Cole TAB-2 Table W/Model Cole SFD-2 SpotfilmKXJ · Traditional | 03/31/1993SE |
| K921991 | Plato Radiation Therapy Planning SystemIYE · Traditional | 11/27/1992SE |
| K915622 | Plato Brachytheraphy Treatment Planning SystemJAQ · Traditional | 09/25/1992SE |
| K911612 | Nucletron Planning SystemIYE · Traditional | 06/13/1991SE |
| K902533 | Pulsed SelectronJAQ · Traditional | 10/12/1990SE |
| K853912 | Microselection Interstitial Remote Afterload SysJAQ · Traditional | 05/21/1986SE |
| K852842 | Selectron HDR Remote AfterloaderJAQ · Traditional | 01/10/1986SE |
Questions and answers
When was Microselectron-Hdr (High Dose Rate) cleared by the FDA?
Microselectron-Hdr (High Dose Rate) (K864210) received a 510(k) decision of Substantially Equivalent on November 26, 1986, 29 days after the submission was received.
What is the product code of K864210?
The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.