Mirada Medical, Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Mirada Medical, Ltd.” (first 2010, latest 2022), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 31 days. Since 2017 the median was 29 days, against 120 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 33 |
| 2014 | 0 | — |
| 2015 | 1 | 246 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 2 | 79 |
| 2019 | 0 | — |
| 2020 | 1 | 29 |
| 2021 | 0 | — |
| 2022 | 1 | 29 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Mirada Medical, Ltd. took a median 29 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 120 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 6 | 6 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 1 | 1 |
| QKB | Radiological Image Processing Software For Radiation Therapy | 1 | 1 |
Review panels
- Radiology (8)
Most recent Mirada Medical, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220779 | XD | LLZ | 2022-04-15 | 29 |
| K202297 | Aline Ablation Intelligence | LLZ | 2020-09-11 | 29 |
| K182016 | Simplicit90Y | LLZ | 2018-12-06 | 132 |
| K181572 | Workflow Box | QKB | 2018-07-10 | 26 |
| K143020 | LiverMultiScan | LNH | 2015-06-23 | 246 |
| K130393 | MIRADA RTX | LLZ | 2013-03-20 | 33 |
| K102687 | MIRADA RT | LLZ | 2010-10-04 | 17 |
| K101228 | MIRADA XD | LLZ | 2010-06-23 | 51 |
Recalls
openFDA lists no recalls under a recalling firm named Mirada Medical, 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 Mirada Medical, 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.
- Mirada Solutions , Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mirada Medical, Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Mirada Medical, Ltd.” (first 2010, latest 2022), across 3 product codes 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 Mirada Medical, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mirada Medical, Ltd. is 31 days. Since 2017: 29 days, versus 120 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Mirada Medical, Ltd.?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 6); LNH (System, Nuclear Magnetic Resonance Imaging, 1); QKB (Radiological Image Processing Software For Radiation Therapy, 1).
Next steps
- See all 8 Mirada Medical, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Mirada Medical, 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.