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510(k) K862144

X-MAT by Combined Concepts, Inc. — Product Code KXJ

K862144 is an FDA 510(k) premarket notification submitted by Combined Concepts, Inc. for the device "X-MAT". The FDA issued a decision of Substantially Equivalent on June 25, 1986. 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
June 25, 1986
Date Received
June 4, 1986
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

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  • 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