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510(k) K854328

MEDEX X-RAY TABLE by Philips Medical Systems (Cleveland), Inc. — Product Code KXJ

K854328 is an FDA 510(k) premarket notification submitted by Philips Medical Systems (Cleveland), Inc. for the device "MEDEX X-RAY TABLE". The FDA issued a decision of Substantially Equivalent on January 28, 1986. The device falls under product code KXJ (Table, Radiologic), a Class II device regulated under 21 CFR 892.1980. Philips Medical Systems (Cleveland), Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1986
Date Received
October 28, 1985
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 Philips Medical Systems (Cleveland), Inc.

  • K171850 — Philips CT Big Bore (November 9, 2017)
  • K172406 — Ingenuity TF (October 6, 2017)
  • K162838 — Philips iCT CT System (April 7, 2017)
  • K163711 — IQon Spectral CT (April 5, 2017)
  • K170086 — Pinnacle Radiation Therapy Planning System (February 9, 2017)
  • K160743 — Philips Ingenuity CT (August 8, 2016)
  • K153444 — Philips Multislice CT System with Low Dose CT Lung Cancer (April 8, 2016)
  • K130992 — PINNACLE3 RADIATION THERAPY PLANNING SYSTEM (June 14, 2013)
  • K111336 — EBW NM 2.0 (May 24, 2011)
  • K111024 — JETPACK 2.0 (April 21, 2011)

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