The following data is part of a premarket notification filed by Direx Systems Corp. with the FDA for Trackleaf-10.
| Device ID | K071701 |
| 510k Number | K071701 |
| Device Name: | TRACKLEAF-10 |
| Classification | Accelerator, Linear, Medical |
| Applicant | DIREX SYSTEMS CORP. 437 TURNPIKE ST. Canton, MA 02021 |
| Contact | Larisa Gershtein |
| Correspondent | Larisa Gershtein DIREX SYSTEMS CORP. 437 TURNPIKE ST. Canton, MA 02021 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-21 |
| Decision Date | 2007-07-23 |
| Summary: | summary |