NOBLUS™ Ultrasound Diagnostic System
FDA 510(k) clearance K160559 · decided 2016-10-18
Clearance details
- K-number
- K160559
- Device name
- NOBLUS™ Ultrasound Diagnostic System
- Applicant
- Hitachi Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2016-02-29
- Decision date
- 2016-10-18
- Days to decision
- 232 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Wallingford, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24 recall (Z-1884-2024) | FUJIFILM Healthcare Americas Corporation | 2024-05-22 |