Home / 510(k) Clearances / K102012

510(k) K102012

DIGITAL RADIOGRAPHY by Canon Inc. -Medical Equipment Group — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2010
Date Received
July 16, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
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)
  • K102013 — DIGITAL RETINAL CAMERA (October 29, 2010)

Other clearances for product code MQB

  • K252911 — Lux HD 2530 detector (Lux HD 2530) (October 9, 2025)
  • K250211 — Yushan X-Ray Flat Panel Detector (July 22, 2025)
  • K250665 — SKR 3000 (June 17, 2025)
  • K243734 — Wireless/ Wired X-Ray Flat Panel Detectors (April 18, 2025)
  • K242770 — EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG (March 20, 2025)
  • K243443 — EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXP (March 19, 2025)
  • K243556 — Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) (March 18, 2025)
  • K244010 — ExamVue Apex (February 24, 2025)
  • K243171 — Yushan X-Ray Flat Panel Detector (December 19, 2024)
  • K241319 — SKR 3000 (November 21, 2024)