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510(k) K954565

EXPLOR-X (AZTEH) HF by Chicago X-Ray Systems, Inc. — Product Code EAP

K954565 is an FDA 510(k) premarket notification submitted by Chicago X-Ray Systems, Inc. for the device "EXPLOR-X (AZTEH) HF". The FDA issued a decision of Substantially Equivalent on October 27, 1995. The device falls under product code EAP (Unit, X-Ray, Intraoral), a Class II device regulated under 21 CFR 872.1810. Chicago X-Ray Systems, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1995
Date Received
October 2, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, X-Ray, Intraoral
Device Class
Class II
Regulation Number
872.1810
Review Panel
RA
Submission Type

Other clearances by Chicago X-Ray Systems, Inc.

  • K972968 — ROTOGRAPH PLUS (October 8, 1997)
  • K950667 — AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER (April 6, 1995)
  • K931300 — FLASH DENT (March 21, 1994)

Other clearances for product code EAP

  • K113360 — MEDICAL IMAGE PROCESSING UNIT (February 7, 2012)
  • K102573 — PROVU (TM) DENTAL X-RAY SYSTEM (June 30, 2011)
  • K093453 — MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM (November 30, 2009)
  • K080738 — DENTRON SENSOR (May 13, 2008)
  • K052422 — THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE) (September 27, 2005)
  • K041385 — MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM (June 7, 2004)
  • K960819 — HELIODENT DS (March 29, 1996)
  • K960028 — ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM (March 1, 1996)
  • K953936 — ATLANTIS (December 28, 1995)
  • K951734 — LUMIX 70B (July 20, 1995)

FDA data resources