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510(k) K862734

CEILSTAND, MULTISTAND R & S AND THE BUCKYSTAND by D&R X-Ray Products, Inc. — Product Code IYB

K862734 is an FDA 510(k) premarket notification submitted by D&R X-Ray Products, Inc. for the device "CEILSTAND, MULTISTAND R & S AND THE BUCKYSTAND". The FDA issued a decision of Substantially Equivalent on August 1, 1986. The device falls under product code IYB (Tube Mount, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1770. D&R X-Ray Products, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 1986
Date Received
July 21, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube Mount, X-Ray, Diagnostic
Device Class
Class I
Regulation Number
892.1770
Review Panel
RA
Submission Type

Other clearances by D&R X-Ray Products, Inc.

  • K861942 — COLLIMATOR MODEL A280BLE & MODEL A280-BLM (July 25, 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 IYB

  • K935123 — SUPERSTAND 300 (March 27, 1996)
  • K946261 — MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000 (February 15, 1995)
  • K941017 — F/C/W TUBESTAND (July 29, 1994)
  • K941004 — CTS SYSTEM (July 29, 1994)
  • K940442 — MPR-814 (June 9, 1994)
  • K935004 — MODEL ALPHA TS-2 (December 13, 1993)
  • K933253 — SUPERSTAND 3000 (August 16, 1993)
  • K925716 — BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC (December 17, 1992)
  • K925170 — SHIMADZU X-RAY TUBE STAND BH-100 SERIES (December 7, 1992)
  • K920727 — CEILING TUBE SUPPORT CH-30X (April 16, 1992)

FDA data resources