ECHELON Oval V 5.0 MRI System
FDA 510(k) K151015 · Hitachi Medical Systems America, Inc.
510(k) numberK151015
Submission
- Device name
- ECHELON Oval V 5.0 MRI System
- Applicant
- Hitachi Medical Systems America, Inc.
Twinsburg, OH, US - Received
- April 16, 2015
- Decision date
- July 29, 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 ECHELON Oval V 5.0 MRI System cleared by the FDA?
ECHELON Oval V 5.0 MRI System (K151015) received a 510(k) decision of Substantially Equivalent on July 29, 2015, 104 days after the submission was received.
What is the product code of K151015?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.