510(k) K100417 ยท MUJ System, Planning, Radiation Therapy Treatment
XKNIFE 5
| Applicant | Integra Radionics, Inc., Burlington MA, US |
| Decision | Substantially Equivalent, Apr 8, 2010 |
| Received | Feb 16, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100417
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2013 | Integra LifeSciences Corp. Integra XKnife Stereotactic Radiosurgery and Radiotherapy Treatment Planning,
Software Versions 5.0.1 and 5.0.2.
Intended for use in stereotactic and non-stereotactic (frameless stereotactic), collim Terminated |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.