Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medison Co., Ltd. — Predicate Candidate Screening
24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
15 daysmedian FDA review time
203 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K103397 | ACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2011-02-25 | 98 | 0 |
| K103722 | THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2011-01-05 | 15 | 0 |
| K102065 | SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2010-08-06 | 14 | 0 |
| K101455 | EKO 7 DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2010-07-19 | 55 | 0 |
| K101829 | THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2010-07-16 | 15 | 0 |
| K100186 | MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2010-03-24 | 61 | 0 |
| K093849 | ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2010-01-19 | 34 | 0 |
| K093714 | SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2009-12-10 | 8 | 0 |
| K092159 | ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2009-07-28 | 12 | 0 |
| K081676 | SONOACE X6 DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2008-07-02 | 15 | 0 |
| K080800 | ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2008-04-07 | 17 | 0 |
| K070813 | ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2007-04-10 | 15 | 0 |
| K063580 | SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2006-12-14 | 14 | 0 |
| K061213 | SONOACE PICO DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2006-05-16 | 14 | 0 |
| K060087 | ACCUVIX V7 DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2006-01-24 | 12 | 0 |
| K053530 | SONOACE X4 DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2006-01-03 | 15 | 0 |
| K052911 | ACCUVIX XQ DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2005-10-31 | 14 | 0 |
| K043455 | SA8000 SE DIAGNOSTIC ULTRASOUND SYSTEM | Medison Co., Ltd. | 2004-12-21 | 6 | 0 |
| K031886 | SONOVIEW PRO BY MEDISON CO., LTD. | Medison Co., Ltd. | 2003-06-30 | 12 | 0 |
| K002491 | COMBISON 301 PW ULTRASOUND SYSTEM AND TRANSDUCERS | Medison Co., Ltd. | 2000-08-25 | 11 | 0 |
| K924432 | MEDISON 1500 | Medison Co., Ltd. | 1993-11-24 | 449 | 0 |
| K923246 | SONACE 2000 | Medison Co., Ltd. | 1993-05-20 | 322 | 0 |
| K910342 | SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | Medison Co., Ltd. | 1991-08-19 | 203 | 0 |
| K900505 | SONOACE 88 PORTABLE ULTRASOUND SCANNER | Medison Co., Ltd. | 1990-08-10 | 189 | 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