510(k) K040553 ยท IXI Block, Beam-Shaping, Radiation Therapy
MODIFICATION TO ACCULEAF
| Applicant | Direx Systems Corp., Natick MA, US |
| Decision | Substantially Equivalent, Apr 1, 2004 |
| Received | Mar 2, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040553
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.