Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Image-Guided Neurologics, Inc. — Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
82 daysmedian FDA review time
204 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050772 | NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000 | Image-Guided Neurologics, Inc. | 2005-04-21 | 27 | 0 |
| K043091 | NAVIGUS NEXDRIVE, MODEL MI-3000 | Image-Guided Neurologics, Inc. | 2005-02-07 | 90 | 1 |
| K040334 | NAVIGUS PASSIVE PROBE, MODEL NP-1000 | Image-Guided Neurologics, Inc. | 2004-10-04 | 236 | 1 |
| K040834 | NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000 | Image-Guided Neurologics, Inc. | 2004-06-03 | 64 | 0 |
| K033619 | NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000 | Image-Guided Neurologics, Inc. | 2004-03-02 | 105 | 0 |
| K031885 | NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX | Image-Guided Neurologics, Inc. | 2003-08-21 | 64 | 0 |
| K024201 | NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000 | Image-Guided Neurologics, Inc. | 2003-03-12 | 82 | 0 |
| K023949 | NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES | Image-Guided Neurologics, Inc. | 2003-02-25 | 90 | 0 |
| K022100 | NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, M | Image-Guided Neurologics, Inc. | 2002-09-25 | 89 | 2 |
| K012719 | NAVIGUS II MR | Image-Guided Neurologics, Inc. | 2001-10-22 | 69 | 0 |
| K012366 | NAVIGUS II TRAJECTORY GUIDE | Image-Guided Neurologics, Inc. | 2001-10-01 | 67 | 1 |
| K011971 | NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000 | Image-Guided Neurologics, Inc. | 2001-08-03 | 39 | 0 |
| K001097 | ACTIVE ARRAY CATHETER, MODEL CS-2000 | Image-Guided Neurologics, Inc. | 2001-01-18 | 289 | 0 |
| K001096 | BURR HOLE COVER, MODEL XX | Image-Guided Neurologics, Inc. | 2000-10-25 | 204 | 0 |
| K002330 | NAVIGUS PEEL AWAY INTRODUCER | Image-Guided Neurologics, Inc. | 2000-10-18 | 78 | 0 |
| K001192 | SELF ADHERING NAVIGUS GUIDE | Image-Guided Neurologics, Inc. | 2000-06-07 | 56 | 0 |
| K000195 | CRANIAL DRILL | Image-Guided Neurologics, Inc. | 2000-04-20 | 90 | 0 |
| K993682 | MRI EQUIPMENT COVER | Image-Guided Neurologics, Inc. | 2000-01-20 | 80 | 0 |
| K992796 | ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000 | Image-Guided Neurologics, Inc. | 1999-10-25 | 67 | 0 |
| K992304 | NAVIGUS TRAJECTORY GUIDE, MODEL TG-XXXX | Image-Guided Neurologics, Inc. | 1999-08-27 | 50 | 0 |
| K990907 | REMOTE INTRODUCER, MODEL PI-1000 | Image-Guided Neurologics, Inc. | 1999-08-12 | 147 | 0 |
| K983539 | TRAJECTORY GUIDE, MODEL # TGX-XXX | Image-Guided Neurologics, Inc. | 1999-02-12 | 126 | 0 |
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