New Search Back To Search Results Device Classification Name system, image processing, radiological 510(k) Number K191530 Device Name StoneChecker Applicant Imaging Biometrics, LLC 13416 Watertown Plank Road, Suite 260 elm grove, WI 53122 Applicant Contact timothy dondlinger Correspondent Imaging Biometrics, LLC 13416 Watertown Plank Road, Suite 260 elm grove, WI 53122 Correspondent Contact timothy dondlinger Regulation Number 892.2050 Classification Product Code LLZ Date Received 06/10/2019 Decision Date 09/26/2019 Decision substantially equivalent (SESE) Regulation Medical Specialty Radiology 510k Review Panel Radiology summary summary Type Traditional Reviewed by Third Party No Combination Product No