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510(k) K853682

MOUNT TUBE RADIOGRAPHIC by X-Ray Systems — Product Code IYB

K853682 is an FDA 510(k) premarket notification submitted by X-Ray Systems for the device "MOUNT TUBE RADIOGRAPHIC". The FDA issued a decision of Substantially Equivalent on September 19, 1985. The device falls under product code IYB (Tube Mount, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1770. X-Ray Systems has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1985
Date Received
September 4, 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 X-Ray Systems

  • K884493 — HEAD HOLDING DEVICE/SLEEP APNEA (January 12, 1989)
  • K855161 — UPRIGHT BUCKY STAND/MOUNT (February 12, 1986)
  • K855052 — TABLE RADIOGRAPHIC FIXED (February 6, 1986)

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