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510(k) K232944

CALLISTO eye by Carl Zeiss Meditec, AG — Product Code NFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2023
Date Received
September 20, 2023
Clearance Type
Special
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

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Other clearances for product code NFJ

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  • 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)
  • K203244 — CellChek 20 rc (June 15, 2021)