510(k) K103493 ยท HBL Holder, Head, Neurosurgical (Skull Clamp)
HEAD FIATION DEVICE (HFD 100)
| Applicant | Imris, Inc., Rockville MD, US |
| Decision | Substantially Equivalent, Mar 11, 2011 |
| Received | Nov 29, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103493
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 8, 2026 | IMRIS Imaging Inc Brand Name: HFD100
Product Name: Head Fixation Device HFD100
Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600
Software Version: Not Applicable
P Open, Classified |
HBL | None listed |
| Feb 17, 2022 | Deerfield Imaging, Inc. Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation device, models #119629-000 and #119630-000, which are used with ORT400 operating Terminated |
HBL | None listed |
| Aug 14, 2017 | Deerfield Imaging IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw Terminated |
HBL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.