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Carestream DRX-1 System with DRX Plus 4343 Detectors

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153142
510(k) Type
Traditional
Applicant
CARESTREAM HEALTH, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/25/2015
Days to Decision
26 days
Submission Type
Summary

Carestream DRX-1 System with DRX Plus 4343 Detectors

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153142
510(k) Type
Traditional
Applicant
CARESTREAM HEALTH, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/25/2015
Days to Decision
26 days
Submission Type
Summary