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510(k) K191615

Huvitz Imaging System by Huvitz Co., Ltd. — Product Code NFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2019
Date Received
June 18, 2019
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

Other clearances by Huvitz Co., Ltd.

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  • K202097 — Fundus Camera (February 2, 2021)
  • K161829 — Huvitz Imaging System (April 6, 2017)
  • K093639 — SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500 (December 3, 2009)
  • K073190 — SLIT LAMP (January 11, 2008)

Other clearances for product code NFJ

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  • 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)