MR Elastography; MZEK-001A
FDA 510(k) K220018 · Canon Medical Systems Corporation
510(k) numberK220018
Submission
- Device name
- MR Elastography; MZEK-001A
- Applicant
- Canon Medical Systems Corporation
Otawara-Shi, JP - Received
- January 5, 2022
- Decision date
- March 3, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was MR Elastography; MZEK-001A cleared by the FDA?
MR Elastography; MZEK-001A (K220018) received a 510(k) decision of Substantially Equivalent on March 3, 2022, 57 days after the submission was received.
What is the product code of K220018?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.