Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Coreline Soft Co., Ltd. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
183 daysmedian FDA review time
365 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251203 | AVIEW Lung Nodule CAD | Coreline Soft Co., Ltd. | 2025-12-03 | 229 | 0 |
| K243689 | AVIEW | Coreline Soft Co., Ltd. | 2025-03-19 | 110 | 0 |
| K243696 | AVIEW CAC | Coreline Soft Co., Ltd. | 2025-02-14 | 77 | 0 |
| K233211 | AVIEW CAC | Coreline Soft Co., Ltd. | 2024-03-29 | 183 | 0 |
| K221592 | AVIEW Lung Nodule CAD | Coreline Soft Co., Ltd. | 2023-02-24 | 267 | 0 |
| K214036 | AVIEW | Coreline Soft Co., Ltd. | 2022-12-23 | 365 | 0 |
| K220408 | AVIEW RT ACS | Coreline Soft Co., Ltd. | 2022-11-10 | 269 | 0 |
| K201710 | A View LCS | Coreline Soft Co., Ltd. | 2020-10-16 | 115 | 0 |
| K200714 | AVIEW | Coreline Soft Co., Ltd. | 2020-08-26 | 161 | 0 |
| K193220 | AVIEW LCS | Coreline Soft Co., Ltd. | 2020-05-05 | 166 | 0 |
| K192040 | AVIEW Modeler | Coreline Soft Co., Ltd. | 2019-12-20 | 142 | 0 |
| K171199 | AVIEW | Coreline Soft Co., Ltd. | 2018-10-31 | 555 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda