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510(k) K192348

SICAT Implant V2.0 by Sicat GmbH & Co. KG — Product Code LLZ

K192348 is an FDA 510(k) premarket notification submitted by Sicat GmbH & Co. KG for the device "SICAT Implant V2.0". The FDA issued a decision of Substantially Equivalent on December 4, 2019. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Sicat GmbH & Co. KG has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2019
Date Received
August 29, 2019
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 Sicat GmbH & Co. KG

  • K180262 — SICAT Endo (March 12, 2018)
  • K153291 — SICAT OPTISLEEP (March 31, 2016)
  • K143655 — SICAT OPTIMOTION (October 2, 2015)
  • K133320 — SICAT FUNCTION (February 25, 2014)
  • K103723 — SICAT IMPLANT V1.2 (May 20, 2011)
  • K093090 — GALILEOS IMPLANT, VERSION 1.7 (December 17, 2009)
  • K090119 — SICAT IMPLANT (February 5, 2009)
  • K061472 — GALILEOS IMPLANT, V 1.0 (June 9, 2006)

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