Cleared Traditional

K152847 - DIVA ZSP5812CMI with QUBYX PerfectLum b...

K152847 is an FDA 510(k) clearance for DIVA ZSP5812CMI with QUBYX PerfectLum b..., manufactured by Qubyx , Ltd.. The device is a Class 2 Radiology device with product code PGY cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K152847 · Qubyx , Ltd. · Radiology device
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Nov 2015
Decision
49d
Days
Class 2
Risk

K152847 is an FDA 510(k) clearance for the DIVA ZSP5812CMI with QUBYX PerfectLum bundle. Classified as Display, Diagnostic Radiology (product code PGY), Class II - Special Controls.

Submitted by Qubyx , Ltd. (Nice, FR). The FDA issued a Cleared decision on November 17, 2015 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Qubyx , Ltd. devices

FDA 510(k) Submission Details - K152847

510(k) Number K152847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2015
Decision Date November 17, 2015
Days to Decision 49 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 107d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PGY Device Classification - Class 2, Special Controls

Product Code PGY Display, Diagnostic Radiology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition The Device Is Intended For Use In Displaying Radiological Images For Review, Analysis, And Diagnosis By Trained Medical Practitioners.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - PGY Display, Diagnostic Radiology

All 120
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