Medison America, Inc.
Pleasanton, CA, US
Medison America, Inc. appears in FDA device records in Pleasanton, CA. FDA records list 21 510(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
- 21
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 21 510(k) clearances for Medison America, Inc. between 1993 and 2003. The busiest year on record is 1999, with 5. The most recent is 2003, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 1 |
| 1994 | 1 |
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 3 |
| 1999 | 5 |
| 2000 | 4 |
| 2001 | 3 |
| 2003 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K032329 | SA 9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K031552 | MYCOLOR 202 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS | IYN | Substantially Equivalent | |
| K013627 | SONOACE SA-8000 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K012887 | SA6000II DIAGNOSTIC ULTRASOUND SYSTEM | IYO | Substantially Equivalent | |
| K012867 | SONOACE 9900 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K003525 | VOLUSON 730 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K003121 | MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS | IYO | Substantially Equivalent | |
| K002185 | SONOACE SA 9900 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K000030 | SONOACE 600 DIAGNOSTIC ULTRASOUND SYSTEM | IYO | Substantially Equivalent | |
| K993517 | COMBISON 530D/VOLUSON 530D, TISSUE HARMONIC IMAGING (THI) OPTION | IYO | Substantially Equivalent | |
| K992761 | SONOACE 5500 DIAGNOSTIC ULTRASOUND SYSTEM | IYO | Substantially Equivalent | |
| K984639 | THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER | ITX | Substantially Equivalent | |
| K992155 | VOLUSION SMALL PARTS TRANSDUCER, MODEL S-VNW 5-10, VOLUSION ABDOMINAL TRANSDUCER, MODEL S-VAW 4-7 | ITX | Substantially Equivalent | |
| K990970 | SONOACE 6000C DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, ALSO CALLED ULTRASOUND SYSTEM AND TRANSDUCERS | IYN | Substantially Equivalent | |
| K974813 | COMBISON 530D WITH POWER DOPPLER MODE | IYN | Substantially Equivalent | |
| K974269 | SA8800 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, | IYN | Substantially Equivalent | |
| K981510 | SONOACE 6000/ ULTRAMARK 400 | IYO | Substantially Equivalent | |
| K940942 | COMBISON 530 DIAGNOSTIC ULTRASOUND SCANNER | IYO | Substantially Equivalent | |
| K953773 | 6.5 MHZ ENDORECTAL CONVEX ARRAY (10R) PROBE | IYO | Substantially Equivalent | |
| K925582 | MEDISON 4800 | IYO | Substantially Equivalent | |
| K930579 | MEDISON 88P DIAGNOSTIC ULTRASOUND IMAGING SYTEM | IYO | 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