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510(k) K101039

SHIMADZU COLLIMATOR R-300 by Shimadzu Corp. — Product Code IZW

K101039 is an FDA 510(k) premarket notification submitted by Shimadzu Corp. for the device "SHIMADZU COLLIMATOR R-300". The FDA issued a decision of Substantially Equivalent on September 20, 2010. The device falls under product code IZW (Collimator, Automatic, 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
September 20, 2010
Date Received
April 14, 2010
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collimator, Automatic, 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)
  • K101036 — SHIMADZU COLLIMATOR R-20J (August 26, 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 IZW

  • K093572 — R650 QDASM COLLIMATOR (February 3, 2010)
  • K090578 — SHIMADZU COLLIMATOR R-30H (November 6, 2009)
  • K091517 — RALCO, MODEL R225 ACS (July 14, 2009)
  • K083029 — MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR (December 5, 2008)
  • K072780 — MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR (November 26, 2007)
  • K073124 — COLLIMARE COLLIMATOR FAMILY (November 16, 2007)
  • K050092 — R605 FACS COLLIMETER (January 31, 2005)
  • K031597 — DUNLEE FORMAT COLLIMATOR FAMILY (July 21, 2003)
  • K990423 — PHILIPS NICOL COLLIMATOR FAMILY (March 15, 1999)
  • K984414 — XRE COLLIMATOR WITH SPECTRAL FILTER (December 30, 1998)

FDA data resources