Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Chison Medical Imaging Co., Ltd. · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
81 daysmedian FDA review time
118 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K170870 | Site~Rite Halcyon Diagnostic Ultrasound System | Chison Medical Imaging Co., Ltd. | 2017-07-06 | 105 | 0 |
| K170374 | SonoBook Series Diagnostic Ultrasound System | Chison Medical Imaging Co., Ltd. | 2017-06-06 | 119 | 0 |
| K162172 | EBit Series Diagnostic Ultrasound System | Chison Medical Imaging Co., Ltd. | 2016-09-14 | 42 | 0 |
| K153085 | Q Series Diagnostic Ultrasound System | Chison Medical Imaging Co., Ltd. | 2015-12-21 | 56 | 0 |
| K150861 | QBit Series Diagnostic Ultrasound System | Chison Medical Imaging Co., Ltd. | 2015-07-28 | 118 | 0 |
| K140364 | CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PR | Chison Medical Imaging Co., Ltd. | 2014-06-02 | 110 | 0 |
| K131305 | CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PR | Chison Medical Imaging Co., Ltd. | 2013-08-01 | 86 | 0 |
| K121867 | SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMS | Chison Medical Imaging Co., Ltd. | 2012-08-02 | 37 | 0 |
| K120801 | CHISON DIAGNOSTIC ULTRASOUND SYSTEM | Chison Medical Imaging Co., Ltd. | 2012-06-14 | 90 | 0 |
| K113359 | CHISON DIAGNOSTIC ULTRASOUND SYSTEM,CONVEX PROBE,LINEAR PROB | Chison Medical Imaging Co., Ltd. | 2012-02-03 | 81 | 0 |
| K091877 | CHISON DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, CONVEX PROBE | Chison Medical Imaging Co., Ltd. | 2009-09-02 | 71 | 0 |
| K072210 | CHISON, MODEL 8300 | Chison Medical Imaging Co., Ltd. | 2007-08-24 | 15 | 0 |
| K050167 | CHISON 600M WITH C60 CONVEX PROBE, L700 LINEAR PROBE | Chison Medical Imaging Co., Ltd. | 2005-02-08 | 13 | 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