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510(k) K945635

TRANS X-1000 by Canon USA, Inc. — Product Code KPX

K945635 is an FDA 510(k) premarket notification submitted by Canon USA, Inc. for the device "TRANS X-1000". The FDA issued a decision of Substantially Equivalent on February 1, 1995. The device falls under product code KPX (Changer, Radiographic Film/Cassette), a Class II device regulated under 21 CFR 892.1860. Canon USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1995
Date Received
November 16, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Changer, Radiographic Film/Cassette
Device Class
Class II
Regulation Number
892.1860
Review Panel
RA
Submission Type

Other clearances by Canon USA, Inc.

  • K090623 — DIGITAL RADIOGRAPHY CXDI-40G COMPACT (March 24, 2009)
  • K033624 — PACS SOFTWARE SOLUTION 2003 (December 15, 2003)
  • K031633 — CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C (June 11, 2003)
  • K031629 — CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI (June 6, 2003)
  • K023750 — CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G (November 22, 2002)
  • K023586 — DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS (November 5, 2002)
  • K003689 — CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31 (January 2, 2002)
  • K992606 — CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100 (June 21, 2000)
  • K992547 — CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22 (October 13, 1999)
  • K981556 — CANON X-RAY DIGITAL CAMERA CXDI-11 (November 4, 1998)

Other clearances for product code KPX

  • K935157 — ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBES (August 9, 1994)
  • K934850 — NUCLEAR ASSOCIATES PERSONNEL PROTECTIVE SHIELDS (November 22, 1993)
  • K933035 — BCM-600TX (October 8, 1993)
  • K925598 — BUCKYMATIC AUTOMATIC CHEST FILM CHANGER (February 1, 1993)
  • K924423 — MWX-7440 HIGH SPEED BUCKY (January 15, 1993)
  • K925169 — SHIMADZU RADIOGRAPJHIC STAND BR-100 (December 3, 1992)
  • K920196 — OX-600 (October 14, 1992)
  • K922483 — DU PONT COMPACT DAYLIGHT SYSTEM 2000 (September 11, 1992)
  • K905789 — FRANKLIN 9000 WALL STAND (May 20, 1991)
  • K902761 — AUTOMATIC CASSETTE LOADER (October 9, 1990)

FDA data resources