Dia Imaging Analysis, Ltd.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Dia Imaging Analysis, Ltd.” (first 2020, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time under this name: 126 days. Since 2017 the median was 126 days, against 140 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 |
|---|---|---|
| 2020 | 2 | 86 |
| 2021 | 2 | 76 |
| 2022 | 0 | — |
| 2023 | 1 | 127 |
| 2024 | 2 | 142 |
| 2025 | 3 | 133 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Dia Imaging Analysis, Ltd. took a median 126 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | 10 | 10 |
Review panels
- Radiology (10)
Most recent Dia Imaging Analysis, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243862 | LVivo Software Application | QIH | 2025-03-17 | 91 |
| K243331 | LVivo Seamless | QIH | 2025-03-06 | 133 |
| K243235 | LVivo Software Application | QIH | 2025-03-03 | 144 |
| K240553 | LVivo Software Application | QIH | 2024-10-04 | 219 |
| K240769 | LVivo IQS | QIH | 2024-05-24 | 64 |
| K222970 | LVivo IQS | QIH | 2023-02-01 | 127 |
| K212466 | LVivo Seamless | QIH | 2021-12-09 | 125 |
| K210053 | LVivo Software Application | QIH | 2021-02-05 | 28 |
| K202546 | LVivo Seamless | QIH | 2020-09-29 | 27 |
| K200232 | LVivo Software Application | QIH | 2020-06-23 | 145 |
Recalls
openFDA lists no recalls under a recalling firm named Dia Imaging Analysis, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Dia Imaging Analysis, Ltd.?
FDA lists 10 510(k) clearances under the applicant name “Dia Imaging Analysis, Ltd.” (first 2020, latest 2025), 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 Dia Imaging Analysis, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dia Imaging Analysis, Ltd. is 126 days. Since 2017: 126 days, versus 140 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Dia Imaging Analysis, Ltd.?
The most frequent FDA product codes under this applicant name are QIH (Automated Radiological Image Processing Software, 10).
Next steps
- See all 10 Dia Imaging Analysis, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code QIH, Dia Imaging Analysis, 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 (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.