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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
K050996
510(k) Type
Abbreviated
Applicant
BREAKAWAY IMAGING, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/5/2005
Days to Decision
15 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
K050996
510(k) Type
Abbreviated
Applicant
BREAKAWAY IMAGING, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/5/2005
Days to Decision
15 days
Submission Type
Summary