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510(k) K942916

OCTOPAQUE UNIVERSAL by Octostop, Inc. — Product Code IXQ

K942916 is an FDA 510(k) premarket notification submitted by Octostop, Inc. for the device "OCTOPAQUE UNIVERSAL". The FDA issued a decision of Substantially Equivalent on September 8, 1994. The device falls under product code IXQ (Table, Radiographic, Stationary Top), a Class II device regulated under 21 CFR 892.1980. Octostop, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1994
Date Received
June 21, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Radiographic, Stationary Top
Device Class
Class II
Regulation Number
892.1980
Review Panel
RA
Submission Type

Other clearances by Octostop, Inc.

  • K972766 — PIVOTING COMPENSATING FILTERS FOR THE HEAD (August 14, 1997)
  • K963941 — THE PHARAOH COMPENSATING FILTER (November 27, 1996)
  • K953246 — OCTOROLL (September 29, 1995)
  • K952871 — RIDGES PLUS (July 20, 1995)
  • K940306 — OCTOSTOP COMPENSATING FILTERS (September 6, 1994)
  • K935444 — OCTOSTOP(R) CHAIR (NEW MODEL (September 2, 1994)
  • K930124 — VARIANT OF OCTOSTOP AND OCTOPAQUE (February 9, 1994)
  • K930357 — ACCESSORY TO UNIVERSAL OCTOPAQUE (July 13, 1993)
  • K926069 — WRIST TRACTION (January 21, 1993)
  • K913659 — LITTLE PRISM (October 14, 1992)

Other clearances for product code IXQ

  • K973842 — CARBON FIBER CONFORMAL COUCH TOP (December 5, 1997)
  • K960083 — MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300 (July 24, 1996)
  • K954225 — MED-TEC HAND GRIP (November 14, 1995)
  • K946262 — EURO, SCST, SCCFT ATLAS RADIOLOGIC TABLES (February 15, 1995)
  • K942190 — ID100 MOBILE FLUOROSCOPIC EXAMINING TABLE (August 17, 1994)
  • K913425 — DIAL-A-RAD PORTA RAD TABLE (November 24, 1992)
  • K923775 — R-MADE HEAD/ARM SUPPORT (October 20, 1992)
  • K920729 — BUCKY TABLE BK-12 (April 27, 1992)
  • K914351 — CLINITRON C-10 (February 14, 1992)
  • K912382 — MILITARY RADIOGRAPHIC FLAT TABLE, CAT # T-9130 (October 10, 1991)

FDA data resources