510(k) K013660
- Device
- GENETRA
- Applicant
- RADIOMED CORPORATION
- 510(k) number
- K013660
- Product code
- KXK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-12-05
- Date received
- 2001-11-06
- Regulation
- 892.5730
- Classification name
- Source, Brachytherapy, Radionuclide
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- GORDON ROBERTS
- Address
- One Industrial Way Tyngsboro MA US 01879 01879
FDA Registration Numbers#
- 1222780
- 2184007
- 3036756245
- 3017496466
- 3010813819
- 1531062
- 1424526
- 1123169
- 3005520039
- 3016602874
- 3003440305
- 3006981798
- 3015042204
- 9617477
- 1450662
- 2022694
- 3008807866
- 1054811
- 1424263
- 3003660614
- 2020394
- 1226007
- 3004111573
- 1721676
- 1644312
- 3008236846
- 3033509898
- 2953359
- 3003925093
- 2245437
- 1037598
- 1120804
- 1417485
- 3014663932
- 3025603301
Source Documents#
Other 510(k) Records For Product Code KXK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252296 | OncoPatch | Oncopatch, Inc. | 2025-12-05 |
| K242818 | IsoSphere | Isoaid, LLC | 2025-07-15 |
| K223465 | RadianceTx Radionuclide Brachytherapy Source | Radiance Therapeutics, Inc. | 2023-01-11 |
| K221539 | GammaTile | Gt Medical Technologies | 2022-11-09 |
| K202267 | Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles | Isoray Medical, Inc. | 2020-12-31 |
| K193602 | LV Liberty Vision Model 1 90Yttrium Brachytherapy Source | Lv Liberty Vision Corporation | 2020-05-29 |
| K190839 | GammaTile | Gt Medical Technologies | 2020-01-23 |
| K191324 | CivaDerm | Civatech Oncology, Inc. | 2019-09-20 |
| K190296 | GammaTile | Gt Medical Technologies | 2019-03-13 |
| K180515 | GammaTile | Isoray Medical, Inc. | 2018-07-06 |
| K171487 | Sirius MRI Marker NS | C4 Imaging, LLC | 2017-08-25 |
| K163572 | LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source | Lv Liberty Vision Corp. | 2017-03-15 |
| K163206 | SMD-Sr90-DA Radionuclide Brachytherapy Source | Salutaris Medical Devices, Inc. | 2016-12-15 |
| K162573 | Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source | Source Production and Equipment Co., Inc. | 2016-11-04 |
| K161396 | SPEC Model M23 | Source Production and Equipment Co., Inc. | 2016-08-17 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases