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510(k) K083725

RADPRO ION by Virtual Imaging, Inc. — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2009
Date Received
December 15, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interventional Fluoroscopic X-Ray System
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Interventional fluoroscopy

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  • K092280 — CYPHER DICOM PRINT SOLUTION (October 16, 2009)
  • K070390 — FLUOROPRO RF DIGITAL IMAGING SYSTEM (April 5, 2007)
  • K063262 — AMX4-50 AND AMX4-31 MOBILE DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS (December 26, 2006)
  • K922313 — P-LINK (July 10, 1992)
  • K891695 — VIEW 1000 (October 27, 1989)
  • K864854 — VIEW(TM) IMAGE PROCESSING AND VIEWING STATION (February 26, 1987)

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