Imris, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Imris, Inc.” (first 2006, latest 2015), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 78 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 | 3 | 86 |
| 2013 | 1 | 170 |
| 2014 | 2 | 59 |
| 2015 | 1 | 336 |
| 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 |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 7 | 7 |
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | 3 | 3 |
| MOS | Coil, Magnetic Resonance, Specialty | 2 | 2 |
| HAW | Neurological Stereotaxic Instrument | 1 | 1 |
| JAK | System, X-Ray, Tomography, Computed | 1 | 1 |
Review panels
Most recent Imris, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K143420 | SYMBIS Surgical System | HAW | 2015-10-30 | 336 |
| K141950 | HFD100 ROCKER ARM ACCESSORY | HBL | 2014-09-04 | 48 |
| K133692 | IMRI 1.5T AND IMRI 3T S | LNH | 2014-02-10 | 70 |
| K130224 | ICT | JAK | 2013-07-18 | 170 |
| K123091 | VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T | MOS | 2012-12-27 | 86 |
| K121997 | IMRIS ONCOLOGY PACKAGE | LNH | 2012-08-10 | 32 |
| K113748 | IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD) | HBL | 2012-03-23 | 93 |
| K103493 | HEAD FIATION DEVICE (HFD 100) | HBL | 2011-03-11 | 102 |
| K103506 | 1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300) | MOS | 2011-02-02 | 65 |
| K101813 | IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO | LNH | 2010-10-05 | 98 |
4 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2014-10-01.
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 Imris, 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.
- Imris Imaging, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Imris, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Imris, Inc.” (first 2006, latest 2015), across 5 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 Imris, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Imris, Inc. is 78 days.
Which FDA product codes appear under Imris, Inc.?
The most frequent FDA product codes under this applicant name are LNH (System, Nuclear Magnetic Resonance Imaging, 7); HBL (Holder, Head, Neurosurgical (Skull Clamp), 3); MOS (Coil, Magnetic Resonance, Specialty, 2).
Next steps
- See all 14 Imris, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LNH, Imris, 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.