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510(k) K972966

AXT 150M MANUAL COLLIMATOR (AXT 150M) by Applied X-Ray Technologies, Inc. — Product Code IZX

K972966 is an FDA 510(k) premarket notification submitted by Applied X-Ray Technologies, Inc. for the device "AXT 150M MANUAL COLLIMATOR (AXT 150M)". The FDA issued a decision of Substantially Equivalent on August 21, 1997. The device falls under product code IZX (Collimator, Manual, Radiographic), a Class II device regulated under 21 CFR 892.1610. Applied X-Ray Technologies, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1997
Date Received
August 11, 1997
Clearance Type
Traditional
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 Applied X-Ray Technologies, Inc.

  • K942367 — AXT 1400 SPOTFILM DEVICE (June 6, 1994)
  • K882492 — A.X.T. SPOTFILM DEVICE (July 21, 1988)

Other clearances for product code IZX

  • K110856 — RALCO (August 10, 2011)
  • K101036 — SHIMADZU COLLIMATOR R-20J (August 26, 2010)
  • 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)
  • 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