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510(k) K892196

RADKOR TS10-B by Radkor, Inc. — Product Code IXQ

K892196 is an FDA 510(k) premarket notification submitted by Radkor, Inc. for the device "RADKOR TS10-B". The FDA issued a decision of Substantially Equivalent on April 26, 1989. The device falls under product code IXQ (Table, Radiographic, Stationary Top), a Class II device regulated under 21 CFR 892.1980. Radkor, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1989
Date Received
April 3, 1989
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 Radkor, Inc.

  • K895969 — RADKOR DXG-650R (November 13, 1989)
  • K891395 — RADKOR BS-10 AND BS-10T (April 3, 1989)
  • K883864 — RADKOR SFR-70 (October 19, 1988)
  • K883885 — RADKOR, RF-159 (October 19, 1988)
  • K881701 — RADKOR SFC-21 (September 8, 1988)
  • K881700 — RADKOR KOB-84 (September 2, 1988)
  • K883081 — RADKOR, XG-515 (September 2, 1988)
  • K881696 — RADKOR XG-325 (September 2, 1988)
  • K882563 — RADKOR, CST-18 (July 8, 1988)

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)
  • K942916 — OCTOPAQUE UNIVERSAL (September 8, 1994)
  • 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)

FDA data resources