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i_Space 1.5T Superconducting Magnetic Resonance Imaging System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192650
510(k) Type
Traditional
Applicant
MRI Division, Beijing Wandong Medical Technology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
1/29/2021
Days to Decision
493 days
Submission Type
Summary