Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in CanadaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list IMRIS with 14 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Oct 30, 2015: SYMBIS Surgical System.
| Date | Record | Source |
|---|---|---|
| Oct 30, 2015 | SYMBIS Surgical SystemK143420 · HAW | 510(k) clearances |
| Oct 1, 2014 | IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations or surgical procedures to support and posClass II · One of the three pins that is used to hold the ORT200 table alignment block in place on the floor of the MR Suite went m | Device recalls |
| Sep 4, 2014 | HFD100 ROCKER ARM ACCESSORYK141950 · HBL | 510(k) clearances |
| Feb 10, 2014 | IMRI 1.5T AND IMRI 3T SK133692 · LNH | 510(k) clearances |
| Jul 18, 2013 | ICTK130224 · JAK | 510(k) clearances |
| Dec 27, 2012 | VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3TK123091 · MOS | 510(k) clearances |
| Aug 10, 2012 | IMRIS ONCOLOGY PACKAGEK121997 · LNH | 510(k) clearances |
| Mar 23, 2012 | IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)K113748 · HBL | 510(k) clearances |
| Mar 11, 2011 | HEAD FIATION DEVICE (HFD 100)K103493 · HBL | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
