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510(k) K862828

BSX BUCKY-STAND by Garrels X-Ray Products, Inc. — Product Code IXY

K862828 is an FDA 510(k) premarket notification submitted by Garrels X-Ray Products, Inc. for the device "BSX BUCKY-STAND". The FDA issued a decision of Substantially Equivalent on August 1, 1986. The device falls under product code IXY (Holder, Radiographic Cassette, Wall-Mounted), a Class I device regulated under 21 CFR 892.1880. Garrels X-Ray Products, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 1986
Date Received
July 25, 1986
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 Garrels X-Ray Products, Inc.

  • K862825 — HI-LO ELEVATOR FLAT TABLE (September 4, 1986)
  • K862827 — FCW TUBE STAND (August 1, 1986)
  • K862826 — ITT INTERGRATED TABLE AND TUBESTAND (August 1, 1986)

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)
  • K925934 — WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT (March 4, 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)

FDA data resources