DIVA ZSP5812CMI with QUBYX PerfectLum bundle— 510(k) K152847

Name: FDA 510(k) clearance K152847
Creator: U.S. Food and Drug Administration
Published: 2015-11-17

Substantially Equivalent

Qubyx , Ltd.

FDA 510(k) clearance K152847 for DIVA ZSP5812CMI with QUBYX PerfectLum bundle, Substantially Equivalent on 2015-11-17. Applicant: Qubyx , Ltd.. Device class: 2.

Clearance details

Applicant: Qubyx , Ltd.
Product code: Code PGY
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2015-09-29
Decision date: 2015-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nice, FR

Download summary PDF View on FDA.gov ↗

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