Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical
Wallingford, CT, US
Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical appears in FDA device records in Wallingford, CT. FDA records list 3 510(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
- 3
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 3 510(k) clearances for Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical between 2013 and 2014. The busiest year on record is 2014, with 2. The most recent is 2014, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2014 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K140443 | ARIETTA 60/ARIETTAS60/ARIETTAV60 | IYN | Substantially Equivalent | |
| K134016 | ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER | IYN | Substantially Equivalent | |
| K122537 | PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0 | IYN | 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
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Data as of , FDA export datePage updated Source: openFDA, public domain