Ultrasound System SONIMAGE HS1
FDA 510(k) K151060 · Konica Minolta, Inc.
510(k) numberK151060
Submission
- Device name
- Ultrasound System SONIMAGE HS1
- Applicant
- Konica Minolta, Inc.
Hino-Shi, JP - Received
- April 20, 2015
- Decision date
- June 5, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Ultrasound System SONIMAGE HS1 cleared by the FDA?
Ultrasound System SONIMAGE HS1 (K151060) received a 510(k) decision of Substantially Equivalent on June 5, 2015, 46 days after the submission was received.
What is the product code of K151060?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.