Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medison America, Inc. · Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
15 daysmedian FDA review time
281 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K032329 | SA 9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEM | Medison America, Inc. | 2003-08-06 | 8 | 0 |
| K031552 | MYCOLOR 202 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS | Medison America, Inc. | 2003-05-30 | 11 | 5 |
| K013627 | SONOACE SA-8000 DIAGNOSTIC ULTRASOUND SYSTEM | Medison America, Inc. | 2001-11-16 | 11 | 0 |
| K012867 | SONOACE 9900 DIAGNOSTIC ULTRASOUND SYSTEM | Medison America, Inc. | 2001-09-12 | 16 | 0 |
| K012887 | SA6000II DIAGNOSTIC ULTRASOUND SYSTEM | Medison America, Inc. | 2001-09-12 | 15 | 0 |
| K003525 | VOLUSON 730 DIAGNOSTIC ULTRASOUND SYSTEM | Medison America, Inc. | 2000-11-22 | 7 | 0 |
| K003121 | MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS | Medison America, Inc. | 2000-10-20 | 15 | 0 |
| K002185 | SONOACE SA 9900 DIAGNOSTIC ULTRASOUND SYSTEM | Medison America, Inc. | 2000-08-01 | 13 | 1 |
| K000030 | SONOACE 600 DIAGNOSTIC ULTRASOUND SYSTEM | Medison America, Inc. | 2000-01-19 | 14 | 0 |
| K993517 | COMBISON 530D/VOLUSON 530D, TISSUE HARMONIC IMAGING (THI) OP | Medison America, Inc. | 1999-11-02 | 15 | 0 |
| K992761 | SONOACE 5500 DIAGNOSTIC ULTRASOUND SYSTEM | Medison America, Inc. | 1999-09-01 | 15 | 0 |
| K984639 | THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER | Medison America, Inc. | 1999-07-12 | 193 | 0 |
| K992155 | VOLUSION SMALL PARTS TRANSDUCER, MODEL S-VNW 5-10, VOLUSION | Medison America, Inc. | 1999-07-08 | 13 | 0 |
| K990970 | SONOACE 6000C DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, | Medison America, Inc. | 1999-04-07 | 15 | 0 |
| K974813 | COMBISON 530D WITH POWER DOPPLER MODE | Medison America, Inc. | 1998-09-29 | 280 | 0 |
| K974269 | SA8800 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, | Medison America, Inc. | 1998-08-21 | 281 | 0 |
| K981510 | SONOACE 6000/ ULTRAMARK 400 | Medison America, Inc. | 1998-05-08 | 10 | 0 |
| K940942 | COMBISON 530 DIAGNOSTIC ULTRASOUND SCANNER | Medison America, Inc. | 1997-02-19 | 1086 | 0 |
| K953773 | 6.5 MHZ ENDORECTAL CONVEX ARRAY (10R) PROBE | Medison America, Inc. | 1996-03-14 | 213 | 0 |
| K925582 | MEDISON 4800 | Medison America, Inc. | 1994-12-27 | 782 | 0 |
| K930579 | MEDISON 88P DIAGNOSTIC ULTRASOUND IMAGING SYTEM | Medison America, Inc. | 1993-11-03 | 272 | 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