CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND CONVEX PROBE, PENCIL AND CONVEX PROBE
FDA 510(k) clearance K140364 · decided 2014-06-02
Clearance details
- K-number
- K140364
- Device name
- CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND CONVEX PROBE, PENCIL AND CONVEX PROBE
- Applicant
- Chison Medical Imaging Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2014-02-12
- Decision date
- 2014-06-02
- Days to decision
- 110 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Dublin, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.