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510(k) K090578

SHIMADZU COLLIMATOR R-30H by Shimadzu Corp. — Product Code IZW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2009
Date Received
March 3, 2009
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

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Other clearances for product code IZW

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  • 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)