Home / 510(k) Clearances / K182376

510(k) K182376

Harmony by Topcon Medical Systems, Inc. — Product Code NFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2018
Date Received
August 31, 2018
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 Topcon Medical Systems, Inc.

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  • K123101 — TRC-50DX RETINAL CAMERA (June 5, 2013)
  • K123460 — TRC-NW300 NON-MYDRIATIC RETINAL CAMERA (February 6, 2013)
  • K110489 — SLIT LAMP SL-2G (May 23, 2011)
  • K093313 — SYNERGY (December 2, 2009)
  • K083316 — 3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM (March 13, 2009)
  • K072971 — TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINA (January 13, 2009)
  • K031831 — TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM (December 19, 2003)

Other clearances for product code NFJ

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  • 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)