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510(k) K901839

60 FUNDUS CAMERA CF-60UV by Canon USA, Inc. — Product Code HJI

K901839 is an FDA 510(k) premarket notification submitted by Canon USA, Inc. for the device "60 FUNDUS CAMERA CF-60UV". The FDA issued a decision of Substantially Equivalent on July 5, 1990. The device falls under product code HJI (Lens, Fundus, Hruby, Diagnostic), a Class I device regulated under 21 CFR 886.1395. Canon USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 1990
Date Received
April 24, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Fundus, Hruby, Diagnostic
Device Class
Class I
Regulation Number
886.1395
Review Panel
OP
Submission Type

Other clearances by Canon USA, Inc.

  • K090623 — DIGITAL RADIOGRAPHY CXDI-40G COMPACT (March 24, 2009)
  • K033624 — PACS SOFTWARE SOLUTION 2003 (December 15, 2003)
  • K031633 — CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C (June 11, 2003)
  • K031629 — CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI (June 6, 2003)
  • K023750 — CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G (November 22, 2002)
  • K023586 — DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS (November 5, 2002)
  • K003689 — CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31 (January 2, 2002)
  • K992606 — CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100 (June 21, 2000)
  • K992547 — CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22 (October 13, 1999)
  • K981556 — CANON X-RAY DIGITAL CAMERA CXDI-11 (November 4, 1998)

Other clearances for product code HJI

  • K923670 — BYRNE EXPULSIVE LENS (November 16, 1992)
  • K902138 — STRIPE PROJECTOR (July 5, 1990)
  • K897186 — LASER IMAGING WORK STATION (March 12, 1990)
  • K820223 — OMS QUARTZ INFUSION CONTACT LENS (February 5, 1982)
  • K802971 — LANDERS CONTACT LENS (February 5, 1981)
  • K802927 — SEBESTYEN IRRIGATING CONTACT LENS (February 5, 1981)
  • K760949 — CHARLES IRRIGATING FUNDUS CONTACT LENS (November 11, 1976)

FDA data resources