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510(k) K200385

CONTINUUM PACS by Integrated Ophthalmic Systems, Inc. — Product Code NFJ

K200385 is an FDA 510(k) premarket notification submitted by Integrated Ophthalmic Systems, Inc. for the device "CONTINUUM PACS". The FDA issued a decision of Substantially Equivalent on March 16, 2020. The device falls under product code NFJ (System, Image Management, Ophthalmic), a Class II device regulated under 21 CFR 892.2050.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2020
Date Received
February 18, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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