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510(k) K861941

COLLIMATOR MODEL A280BLMD & MODEL A280BLMP by D&R X-Ray Products, Inc. — Product Code IZX

K861941 is an FDA 510(k) premarket notification submitted by D&R X-Ray Products, Inc. for the device "COLLIMATOR MODEL A280BLMD & MODEL A280BLMP". The FDA issued a decision of Substantially Equivalent on July 25, 1986. The device falls under product code IZX (Collimator, Manual, Radiographic), a Class II device regulated under 21 CFR 892.1610. D&R X-Ray Products, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1986
Date Received
May 20, 1986
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 D&R X-Ray Products, Inc.

  • K862734 — CEILSTAND, MULTISTAND R & S AND THE BUCKYSTAND (August 1, 1986)
  • K861942 — COLLIMATOR MODEL A280BLE & MODEL A280-BLM (July 25, 1986)
  • K861940 — RADIOGRAPHIC TABLES MODELS A71OS-T,A71OT-T,A71OB-T (May 29, 1986)
  • K850948 — TILTING TABLE RADIOGRAPHIC A9006 TOMOJUPITER (April 10, 1985)

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)
  • 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)

FDA data resources