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510(k) K843244

LIGHT BEAM COLLIMATOR by Dealers X-Ray Co., Inc. — Product Code IZW

K843244 is an FDA 510(k) premarket notification submitted by Dealers X-Ray Co., Inc. for the device "LIGHT BEAM COLLIMATOR". The FDA issued a decision of Substantially Equivalent on September 14, 1984. The device falls under product code IZW (Collimator, Automatic, Radiographic), a Class II device regulated under 21 CFR 892.1610.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1984
Date Received
August 20, 1984
Clearance Type
Traditional
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 for product code IZW

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  • 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)

FDA data resources