Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray
FDA 510(k) K030558 · Proxima Therapeutics, Inc.
510(k) numberK030558
Submission
- Device name
- Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray
- Applicant
- Proxima Therapeutics, Inc.
Alpharetta, GA, US - Received
- February 21, 2003
- Decision date
- May 21, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Braxx Biotech Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K041929 | Mammosite II Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories…JAQ · Special | 08/26/2004SE |
| K032067 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TrayJAQ · Traditional | 02/10/2004SE |
| K011690 | Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories TrayJAQ · Traditional | 05/06/2002SESU |
| K003206 | Gliasite Radiation Therapy System (RTS), Model 1020,1030,1040,8150,9005KXK · Traditional | 04/25/2001SE |
Questions and answers
When was Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray cleared by the FDA?
Mammosite Radiation Therapy System (RTS) Tray, Mammosite HDR Afterloader Accessories Tray (K030558) received a 510(k) decision of Substantially Equivalent on May 21, 2003, 89 days after the submission was received.
What is the product code of K030558?
The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.