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KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K120246
510(k) Type
Traditional
Applicant
CARESTREAM HEALTH,INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/28/2012
Days to Decision
214 days
Submission Type
Summary

KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K120246
510(k) Type
Traditional
Applicant
CARESTREAM HEALTH,INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/28/2012
Days to Decision
214 days
Submission Type
Summary