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510(k) K103659

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

K103659 is an FDA 510(k) premarket notification submitted by Trophy for the device "CS 9300, CS 9300C". The FDA issued a decision of Substantially Equivalent on August 18, 2011. The device falls under product code OAS (X-Ray, Tomography, Computed, Dental), a Class II device regulated under 21 CFR 892.1750. Trophy has at least 10 other 510(k) clearances on record.

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

  • K193390 — CS Model+ (April 2, 2020)
  • K200183 — CS 9600 (March 13, 2020)
  • 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)

Other clearances for product code OAS

  • K261748 — Dental Cone-beam Computed Tomography (mDX-15P Series) (July 23, 2026)
  • K250839 — Dental X-ray System (June 11, 2026)
  • K260662 — Dental Cone Beam Computed Tomography System (June 4, 2026)
  • K253935 — medXion NEXUS (May 15, 2026)
  • K260462 — RCT800 (April 9, 2026)
  • K260093 — Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) (March 31, 2026)
  • K252353 — myray ProXIma X6 (March 10, 2026)
  • K253959 — Primevision 3D (February 5, 2026)
  • K251798 — RCT700 (November 25, 2025)
  • K251842 — Dental Computed Tomography X-ray System (November 13, 2025)

FDA data resources