HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k) clearance K034003 · decided 2004-01-08
Clearance details
- K-number
- K034003
- Device name
- HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM
- Applicant
- Philips Ultrasound, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-12-24
- Decision date
- 2004-01-08
- 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
- Bothell, WA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Philips 3D6-2 Ultrasound Transducer recall (Z-1618-2026) | Philips Ultrasound, Inc | 2026-03-24 |
| 3D6-2 Transducer Probe recall (Z-2346-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| C8-4v Transducer Probe recall (Z-2357-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| C8-4v Transducer Probe recall (Z-2358-2025) | Philips Ultrasound, Inc | 2025-08-22 |