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510(k) K951006

KENEX MOBILE CASSETT HOLDER (AS EXHIBIT #7) by Kenex , Ltd. — Product Code IXA

K951006 is an FDA 510(k) premarket notification submitted by Kenex , Ltd. for the device "KENEX MOBILE CASSETT HOLDER (AS EXHIBIT #7)". The FDA issued a decision of Substantially Equivalent on April 3, 1995. The device falls under product code IXA (Cassette, Radiographic Film), a Class II device regulated under 21 CFR 892.1850. Kenex , Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1995
Date Received
February 15, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cassette, Radiographic Film
Device Class
Class II
Regulation Number
892.1850
Review Panel
RA
Submission Type

Other clearances by Kenex , Ltd.

  • K951005 — KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2) (May 4, 1995)
  • K951004 — 2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4) (April 10, 1995)
  • K951003 — KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5) (April 3, 1995)

Other clearances for product code IXA

  • K081557 — PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER (September 10, 2008)
  • K053173 — DS CASSETTE (December 15, 2005)
  • K040378 — KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 (May 24, 2004)
  • K023020 — AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX (September 26, 2002)
  • K021903 — KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE (July 10, 2002)
  • K013686 — KODAK DIRECTVIEW TABLETOP CASSETTE (December 7, 2001)
  • K013229 — LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE (October 12, 2001)
  • K012373 — LIFERAY WL CASSETTE, LIFERAY KW CASSETTE (August 9, 2001)
  • K983918 — RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP) (March 12, 1999)
  • K980722 — TRIMAX RADIOGRAPHIC CASSETTE (March 23, 1998)

FDA data resources