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3.0T 16ch AIR AA

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223378
510(k) Type
Abbreviated
Applicant
GE Healthcare Coils (USA Instruments, Inc.)
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/3/2023
Days to Decision
57 days
Submission Type
Summary

3.0T 16ch AIR AA

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223378
510(k) Type
Abbreviated
Applicant
GE Healthcare Coils (USA Instruments, Inc.)
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/3/2023
Days to Decision
57 days
Submission Type
Summary