The following data is part of a premarket notification filed by Topex, Inc with the FDA for Srt100 Superficial Radiation Therapy System.
| Device ID | K063456 |
| 510k Number | K063456 |
| Device Name: | SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM |
| Classification | System, Therapeutic, X-ray |
| Applicant | TOPEX, INC 10 PRECISION ROAD Danbury, CT 06810 |
| Contact | Anthony Pellegrina |
| Correspondent | Anthony Pellegrina TOPEX, INC 10 PRECISION ROAD Danbury, CT 06810 |
| Product Code | JAD |
| CFR Regulation Number | 892.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-15 |
| Decision Date | 2007-01-09 |
| Summary: | summary |