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510(k) K931724

ELECTROPHYSIOLOGY (EP) TABLE EP 2000 SERIES by Continental X-Ray Corp. — Product Code KXJ

K931724 is an FDA 510(k) premarket notification submitted by Continental X-Ray Corp. for the device "ELECTROPHYSIOLOGY (EP) TABLE EP 2000 SERIES". The FDA issued a decision of Substantially Equivalent on June 14, 1993. The device falls under product code KXJ (Table, Radiologic), a Class II device regulated under 21 CFR 892.1980. Continental X-Ray Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1993
Date Received
March 24, 1993
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 Continental X-Ray Corp.

  • K972442 — CEILING MOUNTED LATERAL POSITIONER, MODEL NO. 6896.002 (September 11, 1997)
  • K962140 — ICT-2000, INTEGRATED C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITION (July 25, 1996)
  • K961690 — CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105 (June 27, 1996)
  • K954581 — ARC SERIES (December 21, 1995)
  • K950571 — LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270 (March 31, 1995)
  • K942175 — LINEAR TOMOGRAPHIC SYSTEM: PMT 6000 (August 17, 1994)
  • K942100 — MODEL TM EP HIGH VOLTAGE GENERATOR (June 7, 1994)
  • K934686 — MOLYBDENUM/RHODIUM FILTERS (May 26, 1994)
  • K925934 — WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT (March 4, 1993)
  • K921986 — PATIENT INFORMATION MANAGER (PIM) (October 16, 1992)

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)
  • 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