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510(k) K963905

RADIOGRAPHIC ITT TABLE by X-Ray Technologies, Inc. — Product Code KXJ

K963905 is an FDA 510(k) premarket notification submitted by X-Ray Technologies, Inc. for the device "RADIOGRAPHIC ITT TABLE". The FDA issued a decision of Substantially Equivalent on November 12, 1996. The device falls under product code KXJ (Table, Radiologic), a Class II device regulated under 21 CFR 892.1980.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1996
Date Received
September 30, 1996
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 for product code KXJ

  • K050190 — APOLLO (March 25, 2005)
  • 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)
  • K913121 — OMNIFLEX OVERHEAD TUBECRANE CAT.#S-9108/#6713.400 (August 16, 1991)

FDA data resources