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510(k) K113419

CS IMAGING by Trophy — Product Code LLZ

K113419 is an FDA 510(k) premarket notification submitted by Trophy for the device "CS IMAGING". The FDA issued a decision of Substantially Equivalent on February 16, 2012. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Trophy has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2012
Date Received
November 18, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

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)
  • K103659 — CS 9300, CS 9300C (August 18, 2011)

Other clearances for product code LLZ

  • K262449 — AdvaView (August 14, 2026)
  • K261916 — NeuroQuant PET (August 12, 2026)
  • K260936 — RadioViewAI (July 31, 2026)
  • K260588 — Cleerly LABS (July 29, 2026)
  • K262462 — TheraSphere 360™ Y-90 Management Platform (July 24, 2026)
  • K262143 — ImageGrid StreamVue (July 23, 2026)
  • K260500 — ResolutionMD (July 21, 2026)
  • K262120 — Avara Viewer (July 10, 2026)
  • K253899 — 3D-Anywhere (July 9, 2026)
  • K261465 — INDIRA CLOUD VIEWER (July 6, 2026)

FDA data resources