FDA.reportPublic FDA data

510(k) K951734

Device
Lumix 70b
Applicant
EMIX U.S.A., INC.
510(k) number
K951734
Product code
EAP
Decision
Substantially Equivalent (SESE)
Decision date
1995-07-20
Date received
1995-04-14
Regulation
872.1810
Classification name
Unit, X-Ray, Intraoral
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JACK H FAUDE
Address
222 Fox Run Rd. King Of Prussia PA US 19406 19406

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EAP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K113360MEDICAL IMAGE PROCESSING UNITHumanray Co,Ltd2012-02-07
K102573PROVU (TM) DENTAL X-RAY SYSTEMAdvanced Image Science, Inc.2011-06-30
K093453MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMSchick Technologies, Inc.2009-11-30
K080738DENTRON SENSORDentron Systems, LLC2008-05-13
K052422THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)Flow X-Ray Corp.2005-09-27
K041385MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMSchick Technologies, Inc.2004-06-07
K960819HELIODENT DSPelton & Crane Co.1996-03-29
K960028ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEMDentsply Intl.1996-03-01
K953936ATLANTISTrophy Radiologie1995-12-28
K954565EXPLOR-X (AZTEH) HFChicago X-Ray Systems, Inc.1995-10-27
K950533TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHYTrophy Radiologie1995-06-30
K950532TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHYTrophy Radiologie1995-04-19
K950667AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMERChicago X-Ray Systems, Inc.1995-04-06
K950030HELIODENT MDPelton & Crane Co.1995-02-03
K934645RADWORKSRadworks Corp.1994-08-17