Portable X-ray System (Model: MINIX-V / MINIX-S)— 510(k) K152859

Substantially Equivalent

Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012)

FDA 510(k) clearance K152859 for Portable X-ray System (Model: MINIX-V / MINIX-S), Substantially Equivalent on 2015-12-03. Applicant: Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012).

Clearance details

Applicant: Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012)
Product code: Code EHD
Advisory panel: Dental
Date received: 2015-09-30
Decision date: 2015-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

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