OASIS MRI System
FDA 510(k) K211406 · Hitachi Healthcare Americas
510(k) numberK211406
Submission
- Device name
- OASIS MRI System
- Applicant
- Hitachi Healthcare Americas
Twinsburg, OH, US - Received
- May 6, 2021
- Decision date
- October 7, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was OASIS MRI System cleared by the FDA?
OASIS MRI System (K211406) received a 510(k) decision of Substantially Equivalent on October 7, 2021, 154 days after the submission was received.
What is the product code of K211406?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.