CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System
FDA 510(k) clearance K162329 · decided 2016-09-14
Clearance details
- K-number
- K162329
- Device name
- CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System
- Applicant
- Philips Health Care
- Decision
- Substantially Equivalent
- Date received
- 2016-08-19
- Decision date
- 2016-09-14
- Days to decision
- 26 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
+ Add to Predicate Builder ◉ Watch Philips Health Care
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| C9-3io Transducer Probe recall (Z-2361-2025) | Philips Ultrasound, Inc | 2025-08-22 |
| L10-4LAP Transducer Probe recall (Z-2370-2025) | Philips Ultrasound, Inc | 2025-08-22 |