Lux 35 Detector— 510(k) K203159

Substantially Equivalent

Carestream Health

FDA 510(k) clearance K203159 for Lux 35 Detector, Substantially Equivalent on 2020-12-02. Applicant: Carestream Health.

Clearance details

Applicant
Carestream Health
Product code
Code MQB
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Rochester, NY, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.