Medison Co., Ltd.
San Leandro, CA, US
Medison Co., Ltd. appears in FDA device records in San Leandro, CA. FDA records list 24 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 24
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 24 510(k) clearances for Medison Co., Ltd. between 1990 and 2011. The busiest year on record is 2010, with 5. The most recent is 2011, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 1 |
| 1991 | 1 |
| 1993 | 2 |
| 2000 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 4 |
| 2007 | 1 |
| 2008 | 2 |
| 2009 | 2 |
| 2010 | 5 |
| 2011 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K103397 | ACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K103722 | THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM | ITX | Substantially Equivalent | |
| K102065 | SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K101455 | EKO 7 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K101829 | THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM | ITX | Substantially Equivalent | |
| K100186 | MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K093849 | ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K093714 | SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM | ITX | Substantially Equivalent | |
| K092159 | ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K081676 | SONOACE X6 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K080800 | ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K070813 | ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K063580 | SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K061213 | SONOACE PICO DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K060087 | ACCUVIX V7 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K053530 | SONOACE X4 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K052911 | ACCUVIX XQ DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K043455 | SA8000 SE DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K031886 | SONOVIEW PRO BY MEDISON CO., LTD. | LLZ | Substantially Equivalent | |
| K002491 | COMBISON 301 PW ULTRASOUND SYSTEM AND TRANSDUCERS | IYN | Substantially Equivalent | |
| K924432 | MEDISON 1500 | IYO | Substantially Equivalent | |
| K923246 | SONACE 2000 | IYO | Substantially Equivalent | |
| K910342 | SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | IYO | Substantially Equivalent | |
| K900505 | SONOACE 88 PORTABLE ULTRASOUND SCANNER | HEM | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain