Home / 510(k) Clearances / K081797

510(k) K081797

IMAGE STORAGE SYSTEM, MODEL KSS-400 by Konan Medical, Inc. — Product Code NFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2009
Date Received
June 25, 2008
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.

  • K203244 — CellChek 20 rc (June 15, 2021)
  • K191558 — Konan Specular Microscope XVII (March 26, 2020)
  • K120264 — KONAN SPECULAR MICROSCOPE XIV (April 11, 2012)
  • 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

  • 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)
  • K211715 — RetinAI Discovery (April 28, 2022)
  • K210396 — Harmony Referral System (September 13, 2021)