Home / 510(k) Clearances / K861942

510(k) K861942

COLLIMATOR MODEL A280BLE & MODEL A280-BLM by D&R X-Ray Products, Inc. — Product Code IZW

K861942 is an FDA 510(k) premarket notification submitted by D&R X-Ray Products, Inc. for the device "COLLIMATOR MODEL A280BLE & MODEL A280-BLM". The FDA issued a decision of Substantially Equivalent on July 25, 1986. The device falls under product code IZW (Collimator, Automatic, 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, Automatic, 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)
  • K861941 — COLLIMATOR MODEL A280BLMD & MODEL A280BLMP (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 IZW

  • K101039 — SHIMADZU COLLIMATOR R-300 (September 20, 2010)
  • 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