Microselectron Hdr- Genie Afterloading System, Model 105.989 for 115VOLT Devices and 105.988 for 230VOLT Devices
FDA 510(k) K021286 · Nucletron Corp.
510(k) numberK021286
Submission
- Device name
- Microselectron Hdr- Genie Afterloading System, Model 105.989 for 115VOLT Devices and 105.988 for 230VOLT Devices
- Applicant
- Nucletron Corp.
Columbia, MD, US - Received
- April 23, 2002
- Decision date
- May 23, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Microselectron Hdr- Genie Afterloading System, Model 105.989 for 115VOLT Devices and 105.988 for 230VOLT Devices cleared by the FDA?
Microselectron Hdr- Genie Afterloading System, Model 105.989 for 115VOLT Devices and 105.988 for 230VOLT Devices (K021286) received a 510(k) decision of Substantially Equivalent on May 23, 2002, 30 days after the submission was received.
What is the product code of K021286?
The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.