Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OEB · Predicate Candidate Screening
20 FDA 510(k) clearances under this product code; the 50 most recent screened below.
146 daysmedian FDA review time
267 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254075 | Synapse Lung Nodule AI | Fujifilm Corporation | 2026-05-27 | 160 | 0 |
| K251203 | AVIEW Lung Nodule CAD | Coreline Soft Co., Ltd. | 2025-12-03 | 229 | 0 |
| K240554 | InferRead Lung CT.AI | Infervision Medical Technology Co., Ltd. | 2025-05-16 | 443 | 0 |
| K242919 | V5med Lung AI | V5med, Inc. | 2025-03-27 | 184 | 0 |
| K231157 | syngo.CT Lung CAD (Version VD30) | Siemens Healthcare GmbH | 2023-07-19 | 86 | 0 |
| K221592 | AVIEW Lung Nodule CAD | Coreline Soft Co., Ltd. | 2023-02-24 | 267 | 0 |
| K221612 | ClearRead CT | Riverain Technologies, Inc. | 2022-12-05 | 185 | 0 |
| K203258 | syngo.CT Lung CAD | Siemens Healthcare GmbH | 2021-03-31 | 146 | 0 |
| K201501 | Veolity | MeVis Medical Solutions AG | 2021-02-23 | 263 | 0 |
| K192880 | InferRead Lung CT.AI | Beijing Infervision Technology Co., Ltd. | 2020-07-02 | 267 | 0 |
| K193216 | syngo.CT Lung CAD | Siemens Medi Cal Solutions, Inc. | 2020-03-09 | 109 | 0 |
| K161201 | ClearRead CT | Riverain Technologies, LLC | 2016-09-09 | 134 | 0 |
| K143196 | syngo.CT Lung CAD | Siemens AG Medical Solutions | 2015-05-12 | 187 | 0 |
| K043617 | IMAGECHECKER CT CAD SOFTWARE SYSTEM | Hologic, Inc. | 2007-12-21 | 25 | 0 |
| K063877 | SYNGO LUNG CAD | Siemens Medical Solutions USA, Inc. | 2006-10-18 | 6 | 0 |
| K042694 | ADVANCED LUNG ANALYSIS II | GE Medical Systems | 2004-11-18 | 49 | 0 |
| K041807 | LUNG CAR 1.1 | Medicsight | 2004-07-22 | 16 | 0 |
| K041380 | IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICAT | R2 Technology, Inc. | 2004-06-08 | 14 | 0 |
| K033412 | MEDICLUNG, RELEASE 1 | Medicsight | 2003-12-30 | 64 | 0 |
| K033374 | LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY | Siemens AG Medical Solutions | 2003-11-06 | 15 | 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