510(k) K072454 ยท IYE Accelerator, Linear, Medical
INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS
| Applicant | Integra Radionics, Inc., Burlington MA, US |
| Decision | Substantially Equivalent, Oct 16, 2007 |
| Received | Aug 31, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072454
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 8, 2012 | Integra LifeSciences Corp Integra InterFix CT Adapter (CTA)
Intended for cranial fixation during CT scanning and
treatment with the TomoTherapy HiArt (Torno) System
The Integra InterFix CT Adapter (CTA) kits are intended for Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.