Home / 510(k) Clearances / K171370

510(k) K171370

IMAGEnet 6 Ophthalmic Data System by Topcon Corporation — Product Code NFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2017
Date Received
May 10, 2017
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 Topcon Corporation

  • K253039 — AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA (November 7, 2025)
  • K241081 — 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic (July 17, 2024)
  • K233561 — 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) (April 10, 2024)
  • K232828 — IMAGEnet6 Ophthalmic Data System (March 1, 2024)
  • K231222 — 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) (October 30, 2023)
  • K221111 — Non-Mydriatic Retinal Camera NW500 (August 29, 2022)
  • K173119 — DRI OCT Triton (January 19, 2018)
  • K170164 — 3D OCT-1 Maestro (March 3, 2017)
  • K161972 — Slit Lamp SL-D301 (December 9, 2016)
  • K161509 — 3D OCT-1 Maestro (July 28, 2016)

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)