EPIQ Series Diagnostic Ultrasound Systems
FDA 510(k) clearance K202216 · decided 2020-09-02
Clearance details
- K-number
- K202216
- Device name
- EPIQ Series Diagnostic Ultrasound Systems
- Applicant
- Philips Ultrasound, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-08-06
- Decision date
- 2020-09-02
- Days to decision
- 27 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 |
|---|---|---|
| eL18-4 Transducer Probe recall (Z-2369-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| S8-3t Transducer Probe recall (Z-2398-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| V9-2 Transducer Probe recall (Z-2404-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| XL14-3 Transducer Probe recall (Z-2414-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| Philips eL18-4 Transducer. recall (Z-2052-2025) | Philips Ultrasound, Inc | 2025-07-02 |
| Philips eL18-4 EMT Transducer. recall (Z-2053-2025) | Philips Ultrasound, Inc | 2025-07-02 |
| Philips S8-3t Transducer. recall (Z-2061-2025) | Philips Ultrasound, Inc | 2025-07-02 |
| Philips XL14-3 Transducer. recall (Z-2068-2025) | Philips Ultrasound, Inc | 2025-07-02 |