EPIQ Series Diagnostic Ultrasound System
FDA 510(k) clearance K231190 · decided 2023-05-12
Clearance details
- K-number
- K231190
- Device name
- EPIQ Series Diagnostic Ultrasound System
- Applicant
- Philips Ultrasound, LLC
- Decision
- Substantially Equivalent
- Date received
- 2023-04-26
- Decision date
- 2023-05-12
- Days to decision
- 16 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 EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transd recall (Z-1007-2026) | Philips Ultrasound, LLC | 2025-12-31 |
| mL26-8 Transducer Probe recall (Z-2386-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model recall (Z-0283-2024) | Philips Ultrasound, Inc. | 2023-11-09 |
| Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210 recall (Z-0284-2024) | Philips Ultrasound, Inc. | 2023-11-09 |