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510(k) K911563

INVENTOR RT/EXPLORER TRAUMA UNIT by Continental X-Ray Corp. — Product Code IYB

K911563 is an FDA 510(k) premarket notification submitted by Continental X-Ray Corp. for the device "INVENTOR RT/EXPLORER TRAUMA UNIT". The FDA issued a decision of Substantially Equivalent on October 23, 1991. The device falls under product code IYB (Tube Mount, X-Ray, Diagnostic), a Class I device regulated under 21 CFR 892.1770. Continental X-Ray Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1991
Date Received
April 8, 1991
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 Continental X-Ray Corp.

  • K972442 — CEILING MOUNTED LATERAL POSITIONER, MODEL NO. 6896.002 (September 11, 1997)
  • K962140 — ICT-2000, INTEGRATED C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITION (July 25, 1996)
  • K961690 — CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105 (June 27, 1996)
  • K954581 — ARC SERIES (December 21, 1995)
  • K950571 — LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270 (March 31, 1995)
  • K942175 — LINEAR TOMOGRAPHIC SYSTEM: PMT 6000 (August 17, 1994)
  • K942100 — MODEL TM EP HIGH VOLTAGE GENERATOR (June 7, 1994)
  • K934686 — MOLYBDENUM/RHODIUM FILTERS (May 26, 1994)
  • K931724 — ELECTROPHYSIOLOGY (EP) TABLE EP 2000 SERIES (June 14, 1993)
  • K925934 — WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT (March 4, 1993)

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)
  • K941004 — CTS SYSTEM (July 29, 1994)
  • K941017 — F/C/W TUBESTAND (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