ULTRASOUND SYSTEM SONIMAGE HS 1
FDA 510(k) clearance K152577 · decided 2015-10-08
Clearance details
- K-number
- K152577
- Device name
- ULTRASOUND SYSTEM SONIMAGE HS 1
- Applicant
- Konica Minolta, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-09-09
- Decision date
- 2015-10-08
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Hino-Shi, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.