The following data is part of a premarket notification filed by Isoray, Inc with the FDA for Cesitrx, (liquid Cesium-131 Solution) For Use With Gliasite Rts.
| Device ID | K132996 |
| 510k Number | K132996 |
| Device Name: | CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | ISORAY, INC 350 Hills Street Suite 106 Richland, WA 99354 |
| Contact | Fredric Swindler |
| Correspondent | Fredric Swindler ISORAY, INC 350 Hills Street Suite 106 Richland, WA 99354 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-24 |
| Decision Date | 2013-12-17 |
| Summary: | summary |