510(k) K203159— Lux 35 Detector

Substantially Equivalent

Carestream Health

Clearance details

Applicant: Carestream Health
Product code: Code MQB
Advisory panel: Radiology
Date received: 2020-10-23
Decision date: 2020-12-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Rochester, NY, US

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