The following data is part of a premarket notification filed by Direx Systems Corp. with the FDA for Dart-12.
| Device ID | K052705 |
| 510k Number | K052705 |
| Device Name: | DART-12 |
| Classification | Accelerator, Linear, Medical |
| Applicant | DIREX SYSTEMS CORP. 11 MERCER RD. Natick, MA 01760 |
| Contact | Larisa Gershtein |
| Correspondent | Larisa Gershtein DIREX SYSTEMS CORP. 11 MERCER RD. Natick, MA 01760 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-28 |
| Decision Date | 2006-02-21 |
| Summary: | summary |