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510(k) K203244

CellChek 20 rc by Konan Medical, Inc. — Product Code NFJ

K203244 is an FDA 510(k) premarket notification submitted by Konan Medical, Inc. for the device "CellChek 20 rc". The FDA issued a decision of Substantially Equivalent on June 15, 2021. The device falls under product code NFJ (System, Image Management, Ophthalmic), a Class II device regulated under 21 CFR 892.2050. Konan Medical, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2021
Date Received
November 3, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Management, Ophthalmic
Device Class
Class II
Regulation Number
892.2050
Review Panel
OP
Submission Type

Other clearances by Konan Medical, Inc.

  • K191558 — Konan Specular Microscope XVII (March 26, 2020)
  • K120264 — KONAN SPECULAR MICROSCOPE XIV (April 11, 2012)
  • K081797 — IMAGE STORAGE SYSTEM, MODEL KSS-400 (January 22, 2009)
  • K062763 — NONCON ROBO PACHY F&A (February 22, 2008)
  • K040373 — KERATO ANALYZER (EKA) (March 19, 2004)
  • K950091 — KONAN NONCON ROBO SPECULAR MICROSCOPE, MODELS SP 6000 AND SP 8000 (March 1, 1995)

Other clearances for product code NFJ

  • K260694 — ZEISS CLINIC 360 (July 17, 2026)
  • K253893 — Harmony Referral System with Harmony OCT Viewer (Octave) (June 4, 2026)
  • K234076 — iCare ALTIUS CW (August 22, 2024)
  • K232828 — IMAGEnet6 Ophthalmic Data System (March 1, 2024)
  • K232944 — CALLISTO eye (December 21, 2023)
  • K232555 — Harmony (November 20, 2023)
  • K231676 — CALLISTO eye (August 28, 2023)
  • K232088 — Altris IMS (July 31, 2023)
  • K220929 — Excelsior (October 31, 2022)
  • K213527 — FORUM (August 15, 2022)

FDA data resources