Genetra
FDA 510(k) K013660 · Radiomed Corporation
510(k) numberK013660
Submission
- Device name
- Genetra
- Applicant
- Radiomed Corporation
Tyngsboro, MA, US - Received
- November 6, 2001
- Decision date
- December 5, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K252296 | OncoPatchKXK · Traditional | Oncopatch, Inc. | 12/05/2025SE |
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| K193602 | LV Liberty Vision Model 1 90Yttrium Brachytherapy SourceKXK · Special | Lv Liberty Vision Corporation | 05/29/2020SE |
| K190839 | GammaTileKXK · Traditional | Gt Medical Technologies | 01/23/2020SE |
| K191324 | CivaDermKXK · Traditional | Civatech Oncology, Inc. | 09/20/2019SE |
| K190296 | GammaTileKXK · Special | Gt Medical Technologies | 03/13/2019SE |
| K180515 | GammaTileKXK · Traditional | Isoray Medical, Inc. | 07/06/2018SE |
More from Isoray Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K161724 | Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)IYE · Traditional | 04/28/2017SE |
| K120859 | Pre-Loaded Gold Visicoil CK MarkerKXK · Special | 04/19/2012SE |
| K070305 | Pre-Loaded VisicoilIYE · Special | 03/07/2007SE |
| K031206 | Radiomed Soft Tissue MarkerJAK · Special | 05/21/2003SE |
| K022326 | Radiomed MarkerJAK · Traditional | 01/31/2003SE |
| K001070 | Radiomed SourceKXK · Traditional | 10/24/2000SE |
Questions and answers
When was Genetra cleared by the FDA?
Genetra (K013660) received a 510(k) decision of Substantially Equivalent on December 5, 2001, 29 days after the submission was received.
What is the product code of K013660?
The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.