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510(k) K790743

COORDINATUS, HORIZONTAL RADIOGRAPHOC by Pausch Corp. — Product Code KXJ

K790743 is an FDA 510(k) premarket notification submitted by Pausch Corp. for the device "COORDINATUS, HORIZONTAL RADIOGRAPHOC". The FDA issued a decision of Substantially Equivalent on April 23, 1979. The device falls under product code KXJ (Table, Radiologic), a Class II device regulated under 21 CFR 892.1980. Pausch Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1979
Date Received
April 16, 1979
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 Pausch Corp.

  • K081073 — HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F (December 5, 2008)
  • K973864 — COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO (June 17, 1998)
  • K973834 — CS2000 & CS2000 TOMO (April 30, 1998)
  • K903395 — UROMAT 2000 (August 30, 1990)
  • K870856 — COSMOS (March 30, 1987)
  • K790742 — KS-78 VERTICAL WALL CASSETTE HOLDER (April 26, 1979)
  • K790740 — BS 66, UNIVERSAL BUCKY STAND (April 26, 1979)
  • K790741 — COMPACT SYSTEM (April 26, 1979)

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