Brachyseed
FDA 510(k) K000475 · Draximage, Inc.
510(k) numberK000475
Submission
- Device name
- Brachyseed
- Applicant
- Draximage, Inc.
Kirkland, Qc, CA - Received
- February 15, 2000
- Decision date
- August 22, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K190839 | GammaTileKXK · Traditional | Gt Medical Technologies | 01/23/2020SE |
| K191324 | CivaDermKXK · Traditional | Civatech Oncology, Inc. | 09/20/2019SE |
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| K180515 | GammaTileKXK · Traditional | Isoray Medical, Inc. | 07/06/2018SE |
More from Isoray Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K011119 | Brachyseed PD-103 Models #PD1KXK · Abbreviated | 06/25/2001SE |
Questions and answers
When was Brachyseed cleared by the FDA?
Brachyseed (K000475) received a 510(k) decision of Substantially Equivalent on August 22, 2000, 189 days after the submission was received.
What is the product code of K000475?
The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.