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SIGNA PET/MR

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213709
510(k) Type
Traditional
Applicant
GE Medical Systems, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/20/2022
Days to Decision
57 days
Submission Type
Summary

SIGNA PET/MR

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213709
510(k) Type
Traditional
Applicant
GE Medical Systems, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/20/2022
Days to Decision
57 days
Submission Type
Summary