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510(k) K852952

TRAUMA STAND by Xre Corp. — Product Code IYB

K852952 is an FDA 510(k) premarket notification submitted by Xre Corp. for the device "TRAUMA STAND". The FDA issued a decision of Substantially Equivalent on September 26, 1985. The device falls under product code IYB (Tube Mount, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1770. Xre Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1985
Date Received
July 11, 1985
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 Xre Corp.

  • K973744 — UNICATH SP BI-PLANE (MODEL M269 & M289) (December 29, 1997)
  • K961193 — FULL FRAME ZOOM SYSTEM (June 17, 1996)
  • K960998 — XRE COLLIMATOR (April 3, 1996)
  • K945449 — UNICATH LLU ANGIOGRAPHIC SYSTEM (February 27, 1995)
  • K936002 — CINEMAC QAS (September 9, 1994)
  • K933460 — DVFX, MODEL M256 (April 7, 1994)
  • K924828 — BI-N (December 17, 1992)
  • K923654 — POLY DIAGNOST CDX (November 20, 1992)
  • K913685 — UNICATH EP. (November 7, 1991)
  • K912416 — ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM (August 28, 1991)

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