ACHILLES— 510(k) K103633

Substantially Equivalent

Ge Medical Systems China Co., Ltd.

FDA 510(k) clearance K103633 for ACHILLES, Substantially Equivalent on 2011-05-11. Applicant: Ge Medical Systems China Co., Ltd.. Device class: 2.

Clearance details

Applicant: Ge Medical Systems China Co., Ltd.
Product code: Code MUA
Device class: Class 2
Regulation: 21 CFR 892.1180
Advisory panel: Radiology
Date received: 2010-12-13
Decision date: 2011-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wuxi, Jiangsu Province, CN

Download summary PDF View on FDA.gov ↗

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