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510(k) K883885

RADKOR, RF-159 by Radkor, Inc. — Product Code KXJ

K883885 is an FDA 510(k) premarket notification submitted by Radkor, Inc. for the device "RADKOR, RF-159". The FDA issued a decision of Substantially Equivalent on October 19, 1988. The device falls under product code KXJ (Table, Radiologic), 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
October 19, 1988
Date Received
September 13, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Radiologic
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)
  • K892196 — RADKOR TS10-B (April 26, 1989)
  • K891395 — RADKOR BS-10 AND BS-10T (April 3, 1989)
  • K883864 — RADKOR SFR-70 (October 19, 1988)
  • K881701 — RADKOR SFC-21 (September 8, 1988)
  • K881700 — RADKOR KOB-84 (September 2, 1988)
  • K881696 — RADKOR XG-325 (September 2, 1988)
  • K883081 — RADKOR, XG-515 (September 2, 1988)
  • K882563 — RADKOR, CST-18 (July 8, 1988)

Other clearances for product code KXJ

  • K050190 — APOLLO (March 25, 2005)
  • K963905 — RADIOGRAPHIC ITT TABLE (November 12, 1996)
  • K955414 — XRT 400 (July 24, 1996)
  • K951146 — IMAGING TABLE (May 4, 1995)
  • K950068 — CARBON FIBER COUCH INSERT (April 6, 1995)
  • K950442 — INFRARED EXPOSURE HAND SWITCH (March 31, 1995)
  • K940696 — SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5 (March 16, 1994)
  • K931724 — ELECTROPHYSIOLOGY (EP) TABLE EP 2000 SERIES (June 14, 1993)
  • K926407 — MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILM (March 31, 1993)
  • K922098 — CAG-02A (July 27, 1992)

FDA data resources