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KODAK DIRECTVIEW CR MAMMOGRAPHY FEATURE

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
CARESTREAM HEALTH, INC.
Trade Name
KODAK DIRECTVIEW COMPUTED RADIOGRAPHY (CR) MAMMOGRAPHY
Generic Name
Full field digital, system, x-ray, mammographic
Decision Date
11/3/2010
Days to Decision
828 days
Decision Code
APRL
FDA Decision
Reclassification after approval

KODAK DIRECTVIEW CR MAMMOGRAPHY FEATURE

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
CARESTREAM HEALTH, INC.
Trade Name
KODAK DIRECTVIEW COMPUTED RADIOGRAPHY (CR) MAMMOGRAPHY
Generic Name
Full field digital, system, x-ray, mammographic
Decision Date
11/3/2010
Days to Decision
828 days
Decision Code
APRL
FDA Decision
Reclassification after approval