Hitachi Aloka Medical, Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 6
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1696-2017 | Class II | Prosound F75 or F75 The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by trained per | June 11, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K142368 | NOBLUS DIAGNOSTIC ULTRASOUND SCANNER | January 14, 2015 |
| K140854 | INTRA-OPERATIVE ULTRASOUND TRANSDUCER | June 11, 2014 |
| K140639 | PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM | April 16, 2014 |
| K130308 | NOBLUS ULTRASOUND DIAGNOSTIC SYSTEM | April 5, 2013 |
| K123828 | PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM | January 18, 2013 |
| K122341 | PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37 | September 26, 2012 |