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510(k) K853861

CANON X-RAY I.I. RAPID SEQUENCE CAMERA CRS-105 by Canon USA, Inc. — Product Code IJZ

K853861 is an FDA 510(k) premarket notification submitted by Canon USA, Inc. for the device "CANON X-RAY I.I. RAPID SEQUENCE CAMERA CRS-105". The FDA issued a decision of Substantially Equivalent on October 24, 1985. The device falls under product code IJZ (Oil, Clearing), a Class I device regulated under 21 CFR 864.4010. Canon USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1985
Date Received
September 17, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oil, Clearing
Device Class
Class I
Regulation Number
864.4010
Review Panel
HE
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)

FDA data resources