Device Classification Name system, x-ray, extraoral source, digital
510(k) Number K983283
Device Name SIGNET DXIS DIRECT X-RAY IMAGING SYSTEM
Applicant
SIGNET RADIOLOGY, INC.
253 LOGUE RD
P.O. BOX 508
minto, nb,  CA eoe 1jo
Applicant Contact alex cetateanu
Correspondent
SIGNET RADIOLOGY, INC.
253 LOGUE RD
P.O. BOX 508
minto, nb,  CA eoe 1jo
Correspondent Contact alex cetateanu
Regulation Number872.1800
Classification Product Code
MUH  
Date Received09/18/1998
Decision Date 11/06/1998
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No