Aspect Imaging, Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Aspect Imaging, Ltd.” (first 2013, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time under this name: 109 days. Since 2017 the median was 107 days, against 101 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2013 | 1 | 337 |
| 2014 | 1 | 307 |
| 2015 | 0 | — |
| 2016 | 1 | 34 |
| 2017 | 1 | 107 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 2 | 92 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Aspect Imaging, Ltd. took a median 107 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 101 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 6 | 6 |
Review panels
- Radiology (6)
Most recent Aspect Imaging, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261758 | Embrace Vision Neonatal MRI System | LNH | 2026-09-16 | 111 |
| K254277 | Embrace Neonatal MRI System | LNH | 2026-03-13 | 73 |
| K170978 | Embrace Neonatal MRI System | LNH | 2017-07-19 | 107 |
| K160185 | Wrist 3 | LNH | 2016-03-01 | 34 |
| K130692 | M2 WRIST 2 MRI SYSTEM | LNH | 2014-01-14 | 307 |
| K120701 | M2 WRIST MRI SYSTEM | LNH | 2013-02-07 | 337 |
Recalls
openFDA lists no recalls under a recalling firm named Aspect Imaging, Ltd..
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 Aspect Imaging, Ltd. (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.
- Aspect Medical Systems, Inc. (25 510(k)s)
- Aspect Vision Care, Ltd. (5 510(k)s)
- Aspect Electronics, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Aspect Imaging, Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Aspect Imaging, Ltd.” (first 2013, latest 2026), 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 Aspect Imaging, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aspect Imaging, Ltd. is 109 days. Since 2017: 107 days, versus 101 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Aspect Imaging, Ltd.?
The most frequent FDA product codes under this applicant name are LNH (System, Nuclear Magnetic Resonance Imaging, 6).
Next steps
- See all 6 Aspect Imaging, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LNH, Aspect Imaging, Ltd.'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.