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O-ARM IMAGING SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K060344
510(k) Type
Traditional
Applicant
BREAKAWAY IMAGING, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/29/2006
Days to Decision
47 days
Submission Type
Summary

O-ARM IMAGING SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K060344
510(k) Type
Traditional
Applicant
BREAKAWAY IMAGING, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/29/2006
Days to Decision
47 days
Submission Type
Summary