CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM— 510(k) K862323

Name: FDA 510(k) clearance K862323
Creator: U.S. Food and Drug Administration
Published: 1986-08-21

Substantially Equivalent

Canon USA, Inc.

FDA 510(k) clearance K862323 for CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM, Substantially Equivalent on 1986-08-21. Applicant: Canon USA, Inc.. Device class: 2.

Clearance details

Applicant: Canon USA, Inc.
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 1986-06-19
Decision date: 1986-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jericho, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HKI

view all

K253176 — TearView2026-06-22
K251353 — Eyer 22026-01-16
K252120 — Fundus On Phone Non Mydriatic (FOP NM-10)2025-12-12
K250770 — Optina-4C (MHRC-C1N)2025-09-04
K243600 — 3nethra neo HD FA2025-08-14

More clearances from Canon USA, Inc.

view all

K090623 — DIGITAL RADIOGRAPHY CXDI-40G COMPACT2009-03-24
K033624 — PACS SOFTWARE SOLUTION 20032003-12-15
K031633 — CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C2003-06-11
K031629 — CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI2003-06-06
K023750 — CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G2002-11-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.