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510(k) K925934

WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT by Continental X-Ray Corp. — Product Code IXY

K925934 is an FDA 510(k) premarket notification submitted by Continental X-Ray Corp. for the device "WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT". The FDA issued a decision of Substantially Equivalent on March 4, 1993. The device falls under product code IXY (Holder, Radiographic Cassette, Wall-Mounted), a Class I device regulated under 21 CFR 892.1880. Continental X-Ray Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1993
Date Received
November 20, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Radiographic Cassette, Wall-Mounted
Device Class
Class I
Regulation Number
892.1880
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)
  • K921986 — PATIENT INFORMATION MANAGER (PIM) (October 16, 1992)

Other clearances for product code IXY

  • K953402 — UNIVERSIX 190 (August 11, 1995)
  • K953336 — VRS 3 WALL STAND (August 11, 1995)
  • K946114 — SENSORI-MOTOR RATING SCALE (April 28, 1995)
  • K946260 — NTBS-1417, 1436, TBS-1417 (March 31, 1995)
  • K930230 — RADIOGRAPHIC WALL-MOUNTED CASSETTE HOLDER (April 27, 1993)
  • K930249 — BC/WT/PF (April 27, 1993)
  • K924445 — BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKY (February 19, 1993)
  • K922443 — VERT-X UNIVERSAL VERTICAL BUCKY STAND (October 26, 1992)
  • K915667 — MODEL H170 PEDIATRIC CHEST X-RAY UNIT (January 31, 1992)
  • K895034 — BUCKYS MODELS YMB-15A, YMB-15B AND YMB-15C (November 15, 1989)

FDA data resources