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510(k) K102013

DIGITAL RETINAL CAMERA by Canon Inc. -Medical Equipment Group — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2010
Date Received
July 16, 2010
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. -Medical Equipment Group

  • K173689 — Ophthalmic Software Platform RX (February 23, 2018)
  • K123208 — DIGITAL RETINAL CAMERA (March 19, 2013)
  • K121303 — MOBILE C-ARM (July 26, 2012)
  • K111824 — FLAT PANEL DETECTOR (April 23, 2012)
  • K111710 — FULL AUTO TONOMETER MODEL TX-20 (September 20, 2011)
  • K111682 — DIGITAL RADIOGRAPHY (September 2, 2011)
  • K112309 — DIGITAL RADIOGRAPHY (September 2, 2011)
  • K103591 — DIGITAL RADIOGRAPHY (March 29, 2011)
  • K102012 — DIGITAL RADIOGRAPHY (August 17, 2010)

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