Image-Guided Neurologics, Inc.
Melbourne, FL, US
Image-Guided Neurologics, Inc. appears in FDA device records in Melbourne, FL. FDA records list 22 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 22
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 22 510(k) clearances for Image-Guided Neurologics, Inc. between 1999 and 2005. The busiest year on record is 2000, with 5. The most recent is 2005, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 4 |
| 2000 | 5 |
| 2001 | 4 |
| 2002 | 1 |
| 2003 | 3 |
| 2004 | 3 |
| 2005 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K050772 | NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000 | HAW | Substantially Equivalent | |
| K043091 | NAVIGUS NEXDRIVE, MODEL MI-3000 | HAW | Substantially Equivalent | |
| K040334 | NAVIGUS PASSIVE PROBE, MODEL NP-1000 | HAW | Substantially Equivalent | |
| K040834 | NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000 | HAW | Substantially Equivalent | |
| K033619 | NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000 | HAW | Substantially Equivalent | |
| K031885 | NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX | HBL | Substantially Equivalent | |
| K024201 | NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000 | HAW | Substantially Equivalent | |
| K023949 | NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES | HAW | Substantially Equivalent | |
| K022100 | NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010 | HAW | Substantially Equivalent | |
| K012719 | NAVIGUS II MR | HAW | Substantially Equivalent | |
| K012366 | NAVIGUS II TRAJECTORY GUIDE | HAW | Substantially Equivalent | |
| K011971 | NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000 | HAW | Substantially Equivalent | |
| K001097 | ACTIVE ARRAY CATHETER, MODEL CS-2000 | MOS | Substantially Equivalent | |
| K001096 | BURR HOLE COVER, MODEL XX | GXR | Substantially Equivalent | |
| K002330 | NAVIGUS PEEL AWAY INTRODUCER | GWG | Substantially Equivalent | |
| K001192 | SELF ADHERING NAVIGUS GUIDE | HAW | Substantially Equivalent | |
| K000195 | CRANIAL DRILL | HBB | Substantially Equivalent | |
| K993682 | MRI EQUIPMENT COVER | LNH | Substantially Equivalent | |
| K992796 | ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000 | HCA | Substantially Equivalent | |
| K992304 | NAVIGUS TRAJECTORY GUIDE, MODEL TG-XXXX | HAW | Substantially Equivalent | |
| K990907 | REMOTE INTRODUCER, MODEL PI-1000 | HAW | Substantially Equivalent | |
| K983539 | TRAJECTORY GUIDE, MODEL # TGX-XXX | HAW | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain