Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Imris, Inc. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
170 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K143420 | SYMBIS Surgical System | Imris, Inc. | 2015-10-30 | 336 | 0 |
| K141950 | HFD100 ROCKER ARM ACCESSORY | Imris, Inc. | 2014-09-04 | 48 | 0 |
| K133692 | IMRI 1.5T AND IMRI 3T S | Imris, Inc. | 2014-02-10 | 70 | 5 |
| K130224 | ICT | Imris, Inc. | 2013-07-18 | 170 | 0 |
| K123091 | VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T | Imris, Inc. | 2012-12-27 | 86 | 0 |
| K121997 | IMRIS ONCOLOGY PACKAGE | Imris, Inc. | 2012-08-10 | 32 | 0 |
| K113748 | IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD) | Imris, Inc. | 2012-03-23 | 93 | 0 |
| K103493 | HEAD FIATION DEVICE (HFD 100) | Imris, Inc. | 2011-03-11 | 102 | 1 |
| K103506 | 1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300) | Imris, Inc. | 2011-02-02 | 65 | 0 |
| K101813 | IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO | Imris, Inc. | 2010-10-05 | 98 | 4 |
| K091166 | IMRX | Imris, Inc. | 2009-09-02 | 133 | 0 |
| K083137 | NEURO III-SV | Imris, Inc. | 2008-12-16 | 54 | 6 |
| K071099 | NEURO II-SE, MODELS: OR-DR-OR, OR-MB | Imris, Inc. | 2007-05-22 | 33 | 2 |
| K061916 | NEURO II-SE, MODELS OR-MB-DR AND OR-DR | Imris, Inc. | 2006-08-11 | 36 | 2 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda