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510(k) K101036

SHIMADZU COLLIMATOR R-20J by Shimadzu Corp. — Product Code IZX

K101036 is an FDA 510(k) premarket notification submitted by Shimadzu Corp. for the device "SHIMADZU COLLIMATOR R-20J". The FDA issued a decision of Substantially Equivalent on August 26, 2010. The device falls under product code IZX (Collimator, Manual, Radiographic), a Class II device regulated under 21 CFR 892.1610. Shimadzu Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2010
Date Received
April 14, 2010
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collimator, Manual, Radiographic
Device Class
Class II
Regulation Number
892.1610
Review Panel
RA
Submission Type

Other clearances by Shimadzu Corp.

  • K142341 — X-RAY TV SYSTEM SONIALVISION G4 (March 6, 2015)
  • K131075 — X-RAY TV SYSTEM SONIAL VISION G4 (March 28, 2014)
  • K101039 — SHIMADZU COLLIMATOR R-300 (September 20, 2010)
  • K090578 — SHIMADZU COLLIMATOR R-30H (November 6, 2009)
  • K090268 — SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION (June 30, 2009)
  • K080701 — SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION (May 14, 2008)
  • K072006 — DAR-9400F (August 31, 2007)
  • K071717 — GE OEC ALTITUDE (July 5, 2007)
  • K062360 — BRANSIST SAFIRE (October 5, 2006)
  • K050925 — DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE (June 1, 2005)

Other clearances for product code IZX

  • K110856 — RALCO (August 10, 2011)
  • K042840 — SHIMADZU COLLIMATOR R-20J (December 3, 2004)
  • K031771 — SHIMADZU COLLIMATOR R-30H (August 21, 2003)
  • K981267 — FACTS MONOBLOCK (May 6, 1998)
  • K974240 — LIGHTLINE-M (December 22, 1997)
  • K972966 — AXT 150M MANUAL COLLIMATOR (AXT 150M) (August 21, 1997)
  • K932134 — RINN UNIVERSAL COLLIMATOR (July 26, 1993)
  • K912180 — MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM (October 21, 1991)
  • K900007 — R-100-ET MANUAL COLLIMATOR (February 6, 1990)
  • K896486 — R-150-ET COLLIMATOR (January 23, 1990)

FDA data resources