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TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K242015
510(k) Type
Traditional
Applicant
DRGEM Corporation
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
12/16/2024
Days to Decision
159 days
Submission Type
Summary

TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K242015
510(k) Type
Traditional
Applicant
DRGEM Corporation
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
12/16/2024
Days to Decision
159 days
Submission Type
Summary