CX50 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k) clearance K111513 · decided 2011-06-24
Clearance details
- K-number
- K111513
- Device name
- CX50 DIAGNOSTIC ULTRASOUND SYSTEM
- Applicant
- Philips Ultrasound, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-06-01
- Decision date
- 2011-06-24
- Days to decision
- 23 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 |
|---|---|---|
| c5-1 Transducer Probe recall (Z-2352-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| C9-3v Transducer Probe recall (Z-2362-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| D2cwc Transducer Probe recall (Z-2366-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| D5cwc Transducer Probe recall (Z-2368-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| L12-3 Transducer Probe recall (Z-2372-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| X7-2t Transducer Probe recall (Z-2412-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| Philips C5-1 Transducer. recall (Z-2049-2025) | Philips Ultrasound, Inc | 2025-07-02 |
| Philips L12-3 Transducer. recall (Z-2054-2025) | Philips Ultrasound, Inc | 2025-07-02 |
| Philips S5-1 Transducer. recall (Z-2058-2025) | Philips Ultrasound, Inc | 2025-07-02 |
| Philips X7-2t Transducer. recall (Z-2066-2025) | Philips Ultrasound, Inc | 2025-07-02 |