The following data is part of a premarket notification filed by Direx Systems Corp. with the FDA for Modification To Acculeaf.
| Device ID | K040553 |
| 510k Number | K040553 |
| Device Name: | MODIFICATION TO ACCULEAF |
| Classification | Block, Beam-shaping, Radiation Therapy |
| Applicant | DIREX SYSTEMS CORP. 11 MERCER RD. BUSINESS PARK Natick, MA 01760 |
| Contact | Larisa Gershtein |
| Correspondent | Larisa Gershtein DIREX SYSTEMS CORP. 11 MERCER RD. BUSINESS PARK Natick, MA 01760 |
| Product Code | IXI |
| CFR Regulation Number | 892.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-02 |
| Decision Date | 2004-04-01 |
| Summary: | summary |