Aloka Co., Ltd.: FDA filings under this applicant name
FDA lists 39 510(k) clearances under the applicant name “Aloka Co., Ltd.” (first 1982, latest 2011), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 43 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Fujifilm Healthcare, based on public ownership records.
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 | 17 | 17 |
| ITX | Transducer, Ultrasonic, Diagnostic | 8 | 8 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 8 | 8 |
| KRK | Manometer, Blood-Pressure, Venous | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Plus 1 more product codes.
Review panels
- Radiology (34)
- Cardiovascular (1)
Most recent Aloka Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K111227 | ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | 2011-05-13 | 11 |
| K110207 | ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | 2011-02-17 | 23 |
| K093488 | ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM | IYO | 2009-11-20 | 10 |
| K083254 | ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | 2008-12-19 | 45 |
| K081843 | ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1 | LLZ | 2008-07-15 | 15 |
| K080176 | ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | 2008-02-29 | 36 |
| K072285 | ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM | ITX | 2007-08-30 | 14 |
| K060059 | ALOKA SD-3500 ULTRASOUND SYSTEM | IYN | 2006-01-13 | 4 |
| K043196 | ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM | IYN | 2004-11-30 | 12 |
| K040719 | ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM ACCESSORY | IYO | 2004-03-26 | 7 |
29 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Aloka 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.
- Aloka Co. Ltd USA (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Aloka Co., Ltd.?
FDA lists 39 510(k) clearances under the applicant name “Aloka Co., Ltd.” (first 1982, latest 2011), across 6 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 Aloka Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aloka Co., Ltd. is 43 days.
Which FDA product codes appear under Aloka Co., Ltd.?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 17); ITX (Transducer, Ultrasonic, Diagnostic, 8); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 8).
Next steps
- See all 39 Aloka Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IYN, Aloka 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.