The following data is part of a premarket notification filed by Dilon Technologies Llc with the FDA for Gammaloc System, Model 03-00001.
| Device ID | K082588 |
| 510k Number | K082588 |
| Device Name: | GAMMALOC SYSTEM, MODEL 03-00001 |
| Classification | Camera, Scintillation (gamma) |
| Applicant | DILON TECHNOLOGIES LLC 12050 JEFFERSON AVE., SUITE 250 Newport News, VA 23606 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan DILON TECHNOLOGIES LLC 12050 JEFFERSON AVE., SUITE 250 Newport News, VA 23606 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-08 |
| Decision Date | 2009-12-11 |
| Summary: | summary |