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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Sonometer
510(k) Number K103633
Device Name ACHILLES
Applicant
Ge Medical Systems China Co., Ltd.
# 19 Changjiang Rd.
National Hi-Tech Dev. Zone
Wuxi, Jiangsu Province,  CN 214028
Applicant Contact CHRIS PAULIK
Correspondent
Ge Medical Systems China Co., Ltd.
# 19 Changjiang Rd.
National Hi-Tech Dev. Zone
Wuxi, Jiangsu Province,  CN 214028
Correspondent Contact CHRIS PAULIK
Regulation Number892.1180
Classification Product Code
MUA  
Date Received12/13/2010
Decision Date 05/11/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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