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510(k) K061392

IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM by Ikonisys, Inc. — Product Code JOY

K061392 is an FDA 510(k) premarket notification submitted by Ikonisys, Inc. for the device "IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on August 1, 2006. The device falls under product code JOY (Device, Automated Cell-Locating), a Class II device regulated under 21 CFR 864.5260. Ikonisys, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2006
Date Received
May 19, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Automated Cell-Locating
Device Class
Class II
Regulation Number
864.5260
Review Panel
HE
Submission Type

Other clearances by Ikonisys, Inc.

  • K080909 — ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000 (October 17, 2008)
  • K062755 — IKONISCOPE ONCOFISH BLADDER TEST SYSTEM (January 4, 2007)
  • K052577 — IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM (January 24, 2006)

Other clearances for product code JOY

  • K243144 — X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application (June 27, 2025)
  • K221309 — AI100 with Shonit (September 19, 2023)
  • K220013 — X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Applicatio (May 3, 2022)
  • K200595 — CellaVision DC-1, CellaVision DC-1 PPA (October 16, 2020)
  • K201301 — X100 with Full Field Peripheral Blood Smear (PBS) Application (October 2, 2020)
  • K182062 — Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device (October 30, 2018)
  • K171315 — Advanced RBC Application (August 1, 2017)
  • K102778 — CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION (September 16, 2011)
  • K092116 — EASYCELL CELL LOCATOR (May 12, 2010)
  • K092868 — CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 (November 20, 2009)

FDA data resources