Medison America, Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Medison America, Inc.” (first 1993, latest 2003), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 15 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 10 | 10 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 9 | 9 |
| ITX | Transducer, Ultrasonic, Diagnostic | 2 | 2 |
Review panels
- Radiology (21)
Most recent Medison America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K032329 | SA 9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEM | IYN | 2003-08-06 | 8 |
| K031552 | MYCOLOR 202 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS | IYN | 2003-05-30 | 11 |
| K013627 | SONOACE SA-8000 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | 2001-11-16 | 11 |
| K012887 | SA6000II DIAGNOSTIC ULTRASOUND SYSTEM | IYO | 2001-09-12 | 15 |
| K012867 | SONOACE 9900 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | 2001-09-12 | 16 |
| K003525 | VOLUSON 730 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | 2000-11-22 | 7 |
| K003121 | MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS | IYO | 2000-10-20 | 15 |
| K002185 | SONOACE SA 9900 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | 2000-08-01 | 13 |
| K000030 | SONOACE 600 DIAGNOSTIC ULTRASOUND SYSTEM | IYO | 2000-01-19 | 14 |
| K993517 | COMBISON 530D/VOLUSON 530D, TISSUE HARMONIC IMAGING (THI) OPTION | IYO | 1999-11-02 | 15 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medison America, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Medison Co., Ltd. (24 510(k)s)
- Medison Radiology Systems, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medison America, Inc.?
FDA lists 21 510(k) clearances under the applicant name “Medison America, Inc.” (first 1993, latest 2003), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medison America, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medison America, Inc. is 15 days.
Which FDA product codes appear under Medison America, Inc.?
The most frequent FDA product codes under this applicant name are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 10); IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 9); ITX (Transducer, Ultrasonic, Diagnostic, 2).
Next steps
- See all 21 Medison America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYO, Medison America, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.