NUVIS DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k) clearance K133833 · decided 2014-01-17
Clearance details
- K-number
- K133833
- Device name
- NUVIS DIAGNOSTIC ULTRASOUND SYSTEM
- Applicant
- Philips Ultrasound, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-12-17
- Decision date
- 2014-01-17
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Buffalo, MN, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| C5-2 Transducer Probe recall (Z-2353-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| C5-2 Lumify Transducer Probe recall (Z-2354-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| Philips C5-2 Transducer. recall (Z-2050-2025) | Philips Ultrasound, Inc | 2025-07-02 |