The following data is part of a premarket notification filed by Nucletron-oldelft Corp. with the FDA for Plato Brachytheraphy Treatment Planning System.
Device ID | K915622 |
510k Number | K915622 |
Device Name: | PLATO BRACHYTHERAPHY TREATMENT PLANNING SYSTEM |
Classification | System, Applicator, Radionuclide, Remote-controlled |
Applicant | NUCLETRON-OLDELFT CORP. 9160 REDBRANCH RD. Columbia, MD 21045 |
Contact | A. M Mount |
Correspondent | A. M Mount NUCLETRON-OLDELFT CORP. 9160 REDBRANCH RD. Columbia, MD 21045 |
Product Code | JAQ |
CFR Regulation Number | 892.5700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-12-16 |
Decision Date | 1992-09-25 |