Medison Co., Ltd.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Medison Co., Ltd.” (first 1990, latest 2011), across 5 product codes in 2 review panels. 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 |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 16 | 16 |
| ITX | Transducer, Ultrasonic, Diagnostic | 3 | 3 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 3 | 3 |
| HEM | Imager, Ultrasonic Obstetric-Gynecologic | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Review panels
- Radiology (23)
- Obstetrics and Gynecology (1)
Most recent Medison Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103397 | ACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEM | IYN | 2011-02-25 | 98 |
| K103722 | THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM | ITX | 2011-01-05 | 15 |
| K102065 | SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | 2010-08-06 | 14 |
| K101455 | EKO 7 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | 2010-07-19 | 55 |
| K101829 | THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM | ITX | 2010-07-16 | 15 |
| K100186 | MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | 2010-03-24 | 61 |
| K093849 | ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | 2010-01-19 | 34 |
| K093714 | SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM | ITX | 2009-12-10 | 8 |
| K092159 | ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | 2009-07-28 | 12 |
| K081676 | SONOACE X6 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | 2008-07-02 | 15 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medison Co., Ltd..
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 America, Inc. (21 510(k)s)
- Medison Radiology Systems, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medison Co., Ltd.?
FDA lists 24 510(k) clearances under the applicant name “Medison Co., Ltd.” (first 1990, latest 2011), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medison Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medison Co., Ltd. is 15 days.
Which FDA product codes appear under Medison Co., Ltd.?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 16); ITX (Transducer, Ultrasonic, Diagnostic, 3); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 3).
Next steps
- See all 24 Medison Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IYN, Medison Co., Ltd.'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.