CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k) clearance K120321 · decided 2012-02-17
Clearance details
- K-number
- K120321
- Device name
- CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM
- Applicant
- Philips Health Care
- Decision
- Substantially Equivalent
- Date received
- 2012-02-02
- Decision date
- 2012-02-17
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Andover, MA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Philips S4-1 Ultrasound Transducer recall (Z-1625-2026) | Philips Ultrasound, Inc | 2026-03-24 |
| C5-2 Transducer Probe recall (Z-2353-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| C9-4v Transducer Probe recall (Z-2364-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| L12-4 Transducer Probe recall (Z-2373-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| S4-1 Transducer Probe recall (Z-2391-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| Philips C5-2 Transducer. recall (Z-2050-2025) | Philips Ultrasound, Inc | 2025-07-02 |
| Philips L12-4 Transducer. recall (Z-2055-2025) | Philips Ultrasound, Inc | 2025-07-02 |
| 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, a recall (Z-2517-2023) | Philips Ultrasound, Inc. | 2023-09-06 |