MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k) clearance K100186 · decided 2010-03-24
Clearance details
- K-number
- K100186
- Device name
- MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM
- Applicant
- Medison Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2010-01-22
- Decision date
- 2010-03-24
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Buffalo, MN, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.