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510(k) K951734

LUMIX 70B by Emix U.S.A., Inc. — Product Code EAP

K951734 is an FDA 510(k) premarket notification submitted by Emix U.S.A., Inc. for the device "LUMIX 70B". The FDA issued a decision of Substantially Equivalent on July 20, 1995. The device falls under product code EAP (Unit, X-Ray, Intraoral), a Class II device regulated under 21 CFR 872.1810. Emix U.S.A., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1995
Date Received
April 14, 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 Emix U.S.A., Inc.

  • K940540 — VELO ACE (July 18, 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)
  • K954565 — EXPLOR-X (AZTEH) HF (October 27, 1995)

FDA data resources