Coreline Soft Co., Ltd.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Coreline Soft Co., Ltd.” (first 2018, latest 2025), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 174 days. Since 2017 the median was 174 days, against 132 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 |
|---|---|---|
| 2018 | 1 | 555 |
| 2019 | 1 | 142 |
| 2020 | 3 | 161 |
| 2021 | 0 | — |
| 2022 | 2 | 317 |
| 2023 | 1 | 267 |
| 2024 | 1 | 183 |
| 2025 | 3 | 110 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Coreline Soft Co., Ltd. took a median 174 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 132 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 5 | 5 |
| QIH | Automated Radiological Image Processing Software | 4 | 4 |
| OEB | Lung Computed Tomography System, Computer-Aided Detection | 2 | 2 |
| QKB | Radiological Image Processing Software For Radiation Therapy | 1 | 1 |
Review panels
- Radiology (12)
Most recent Coreline Soft Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251203 | AVIEW Lung Nodule CAD | OEB | 2025-12-03 | 229 |
| K243689 | AVIEW | QIH | 2025-03-19 | 110 |
| K243696 | AVIEW CAC | QIH | 2025-02-14 | 77 |
| K233211 | AVIEW CAC | QIH | 2024-03-29 | 183 |
| K221592 | AVIEW Lung Nodule CAD | OEB | 2023-02-24 | 267 |
| K214036 | AVIEW | QIH | 2022-12-23 | 365 |
| K220408 | AVIEW RT ACS | QKB | 2022-11-10 | 269 |
| K201710 | A View LCS | LLZ | 2020-10-16 | 115 |
| K200714 | AVIEW | LLZ | 2020-08-26 | 161 |
| K193220 | AVIEW LCS | LLZ | 2020-05-05 | 166 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Coreline Soft Co., 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 Coreline Soft Co., Ltd.?
FDA lists 12 510(k) clearances under the applicant name “Coreline Soft Co., Ltd.” (first 2018, latest 2025), across 4 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 Coreline Soft Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Coreline Soft Co., Ltd. is 174 days. Since 2017: 174 days, versus 132 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Coreline Soft Co., Ltd.?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 5); QIH (Automated Radiological Image Processing Software, 4); OEB (Lung Computed Tomography System, Computer-Aided Detection, 2).
Next steps
- See all 12 Coreline Soft Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Coreline Soft Co., 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.