ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM

System, X-ray, Extraoral Source, Digital

TAKARA BELMONT USA, INC.

The following data is part of a premarket notification filed by Takara Belmont Usa, Inc. with the FDA for Adr Plus Ssxi Imaging Device For X-ray Systems Such As X-caliber, X-caliber Cm, Ana-bel And Ana-bel Cm.

Pre-market Notification Details

Device IDK041834
510k NumberK041834
Device Name:ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM
ClassificationSystem, X-ray, Extraoral Source, Digital
Applicant TAKARA BELMONT USA, INC. 1129 BLOOMFIELD AVENUE West Caldwell,  NJ  07006
ContactRobert Schiff
CorrespondentRobert Schiff
TAKARA BELMONT USA, INC. 1129 BLOOMFIELD AVENUE West Caldwell,  NJ  07006
Product CodeMUH  
Subsequent Product CodeEHD
Subsequent Product CodeMQB
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-07-07
Decision Date2004-12-03

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