Image-Guided Neurologics, Inc.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Image-Guided Neurologics, Inc.” (first 1999, latest 2005), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 81 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | 15 | 15 |
| GWG | Endoscope, Neurological | 1 | 1 |
| GXR | Cover, Burr Hole | 1 | 1 |
| HBB | Motor, Drill, Pneumatic | 1 | 1 |
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | 1 | 1 |
| HCA | Catheter, Ventricular | 1 | 1 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 1 | 1 |
| MOS | Coil, Magnetic Resonance, Specialty | 1 | 1 |
Review panels
Most recent Image-Guided Neurologics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K050772 | NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000 | HAW | 2005-04-21 | 27 |
| K043091 | NAVIGUS NEXDRIVE, MODEL MI-3000 | HAW | 2005-02-07 | 90 |
| K040334 | NAVIGUS PASSIVE PROBE, MODEL NP-1000 | HAW | 2004-10-04 | 236 |
| K040834 | NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000 | HAW | 2004-06-03 | 64 |
| K033619 | NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000 | HAW | 2004-03-02 | 105 |
| K031885 | NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX | HBL | 2003-08-21 | 64 |
| K024201 | NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000 | HAW | 2003-03-12 | 82 |
| K023949 | NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES | HAW | 2003-02-25 | 90 |
| K022100 | NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010 | HAW | 2002-09-25 | 89 |
| K012719 | NAVIGUS II MR | HAW | 2001-10-22 | 69 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Image-Guided Neurologics, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Image-Guided Neurologics, Inc. (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Image Analysis, Inc. (9 510(k)s)
- Image Data Corp. (6 510(k)s)
- Image Diagnostics, Inc. (3 510(k)s)
- Image Systems, Inc. (3 510(k)s)
- Image Diagnost International GmbH (2 510(k)s)
- Image Stream Medical, Inc. (2 510(k)s)
- Image Analysis Limited (1 510(k)s)
- Image Enhancements (1 510(k)s)
- Image Information Systems, Ltd. (1 510(k)s)
- Image Instruments GmbH (1 510(k)s)
- Image Medical, Inc. (1 510(k)s)
- Image of Hawaii (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Image-Guided Neurologics, Inc.?
FDA lists 22 510(k) clearances under the applicant name “Image-Guided Neurologics, Inc.” (first 1999, latest 2005), across 8 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Image-Guided Neurologics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Image-Guided Neurologics, Inc. is 81 days.
Which FDA product codes appear under Image-Guided Neurologics, Inc.?
The most frequent FDA product codes under this applicant name are HAW (Neurological Stereotaxic Instrument, 15); GWG (Endoscope, Neurological, 1); GXR (Cover, Burr Hole, 1).
Next steps
- See all 22 Image-Guided Neurologics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HAW, Image-Guided Neurologics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.