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510(k) K926407

MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILM by Nucletron-Oldelft Corp. — Product Code KXJ

K926407 is an FDA 510(k) premarket notification submitted by Nucletron-Oldelft Corp. for the device "MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILM". The FDA issued a decision of Substantially Equivalent on March 31, 1993. The device falls under product code KXJ (Table, Radiologic), a Class II device regulated under 21 CFR 892.1980. Nucletron-Oldelft Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1993
Date Received
December 21, 1992
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 Nucletron-Oldelft Corp.

  • K953946 — MICROSELECTRON-HDR VERSION 2 (August 13, 1996)
  • K953831 — N 800 HF (September 8, 1995)
  • K925956 — MICROSELECTRON - HDR FOR MOBILE ENVIRONMENT (November 19, 1993)
  • K921991 — PLATO RADIATION THERAPY PLANNING SYSTEM (November 27, 1992)
  • K915622 — PLATO BRACHYTHERAPHY TREATMENT PLANNING SYSTEM (September 25, 1992)
  • K911612 — NUCLETRON PLANNING SYSTEM (June 13, 1991)
  • K902533 — PULSED SELECTRON (October 12, 1990)
  • K864210 — MICROSELECTRON-HDR (HIGH DOSE RATE) (November 26, 1986)
  • K853912 — MICROSELECTION INTERSTITIAL REMOTE AFTERLOAD SYS (May 21, 1986)
  • K852842 — SELECTRON HDR REMOTE AFTERLOADER (January 10, 1986)

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)
  • K922098 — CAG-02A (July 27, 1992)
  • K913121 — OMNIFLEX OVERHEAD TUBECRANE CAT.#S-9108/#6713.400 (August 16, 1991)

FDA data resources