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510(k) K950442

INFRARED EXPOSURE HAND SWITCH by Medical X-Ray Intl., Inc. — Product Code KXJ

K950442 is an FDA 510(k) premarket notification submitted by Medical X-Ray Intl., Inc. for the device "INFRARED EXPOSURE HAND SWITCH". The FDA issued a decision of Substantially Equivalent on March 31, 1995. 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
March 31, 1995
Date Received
January 27, 1995
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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  • K951146 — IMAGING TABLE (May 4, 1995)
  • K950068 — CARBON FIBER COUCH INSERT (April 6, 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