Aurora Imaging Technology, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Aurora Imaging Technology, Inc.” (first 2001, latest 2008), across 1 product code in 1 review panel. Median 510(k) review time under this name: 70 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 |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 7 | 7 |
Review panels
- Radiology (7)
Most recent Aurora Imaging Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K073425 | MODIFICATION TO AURORA MRI SYSTEM | LNH | 2008-09-16 | 288 |
| K052698 | MODIFICATION TO: AURORA | LNH | 2005-11-08 | 41 |
| K032678 | MODIFICATION TO: AURORA | LNH | 2003-09-24 | 26 |
| K032082 | AURORA | LNH | 2003-07-30 | 23 |
| K023686 | AURORA MR-GUIDED INTERVENTIONAL SYSTEM | LNH | 2003-01-29 | 89 |
| K012154 | AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE | LNH | 2001-09-19 | 70 |
| K003651 | AURORA | LNH | 2001-02-21 | 86 |
Recalls
openFDA lists no recalls under a recalling firm named Aurora Imaging Technology, 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 Aurora Imaging Technology, 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 LNH)
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.
- Aurora Spine, Inc. (10 510(k)s)
- Aurora Technology, Inc. (1 510(k)s)
- Aurora Technology Development, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Aurora Imaging Technology, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Aurora Imaging Technology, Inc.” (first 2001, latest 2008), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Aurora Imaging Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aurora Imaging Technology, Inc. is 70 days.
Which FDA product codes appear under Aurora Imaging Technology, Inc.?
The most frequent FDA product codes under this applicant name are LNH (System, Nuclear Magnetic Resonance Imaging, 7).
Next steps
- See all 7 Aurora Imaging Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LNH, Aurora Imaging Technology, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.