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OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210458
510(k) Type
Traditional
Applicant
Abbott Medical
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/8/2021
Days to Decision
112 days
Submission Type
Summary

OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210458
510(k) Type
Traditional
Applicant
Abbott Medical
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/8/2021
Days to Decision
112 days
Submission Type
Summary