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510(k) K201122

Canon non-mydriatic retinal camera CR series by Canon, Inc. — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2020
Date Received
April 27, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Ophthalmic, Ac-Powered
Device Class
Class II
Regulation Number
886.1120
Review Panel
OP
Submission Type

Other clearances by Canon, Inc.

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  • K230175 — Digital Radiography CXDI-CS01 (February 15, 2023)
  • K222855 — Digital Radiography CXDI-Pro, Digital Radiography D1 (October 17, 2022)
  • K222687 — Digital Radiography CXDI-Elite, Digital Radiography E1 (September 29, 2022)
  • K222661 — Digital Radiography CXDI-CS01 (September 27, 2022)
  • K221876 — Digital Radiography CXDI-Pro, Digital Radiography D1 (July 15, 2022)
  • K221620 — Digital Radiography CXDI-Elite, Digital Radiography E1 (June 14, 2022)
  • K220098 — Digital Radiography CXDI-Pro, Digital Radiography D1 (February 4, 2022)
  • K213780 — DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1 (January 24, 2022)

Other clearances for product code HKI

  • K251353 — Eyer 2 (January 16, 2026)
  • K252120 — Fundus On Phone Non Mydriatic (FOP NM-10) (December 12, 2025)
  • K250770 — Optina-4C (MHRC-C1N) (September 4, 2025)
  • K243600 — 3nethra neo HD FA; 3nethra neo HD (August 14, 2025)
  • K250683 — Resolve Fundus Camera (April 30, 2025)
  • K243664 — Sentinel Camera (December 17, 2024)
  • K242508 — Verily Numetric Retinal Camera (December 9, 2024)
  • K241049 — CANON Fundus Camera CR-10 (CR-10) (May 15, 2024)
  • K231230 — Optina-4C (MHRC-C1N) (December 5, 2023)
  • K230627 — Zilia Ocular FC (ZIL-10002) (November 20, 2023)