QuantumCam— 510(k) K161674

Substantially Equivalent

Ddd-Diagnostic A/S

FDA 510(k) clearance K161674 for QuantumCam, Substantially Equivalent on 2016-10-20. Applicant: Ddd-Diagnostic A/S. Device class: 2.

Clearance details

Applicant: Ddd-Diagnostic A/S
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2016-06-16
Decision date: 2016-10-20
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Horsholm, DK

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.