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510(k) K103659

CS 9300, CS 9300C by Trophy — Product Code OAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2011
Date Received
December 15, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
X-Ray, Tomography, Computed, Dental
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.

Other clearances by Trophy

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  • K181136 — CS 9600 (May 24, 2018)
  • K173622 — CS Imaging (January 16, 2018)
  • K151087 — CS 8100SC, CS8100SC Access (August 21, 2015)
  • K151837 — CS 3D Imaging (August 19, 2015)
  • K141607 — DENTAL IMAGING SOFTWARE (September 18, 2014)
  • K133406 — CS 8100 3D (March 14, 2014)
  • K120975 — CS 8100 CS 8100 ACCESS (June 22, 2012)
  • K113419 — CS IMAGING (February 16, 2012)

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