Cleared Traditional

K160328 - DIVA ZSP2105CMI with QUBYX PerfectLum bundle

K160328 is an FDA 510(k) clearance for DIVA ZSP2105CMI with QUBYX PerfectLum b..., manufactured by The Linden Group Corp. The device is a Class 2 Radiology device with product code PGY cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K160328 · The Linden Group Corp · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
20d
Days
Class 2
Risk

K160328 is an FDA 510(k) clearance for the DIVA ZSP2105CMI with QUBYX PerfectLum bundle. Classified as Display, Diagnostic Radiology (product code PGY), Class II - Special Controls.

Submitted by The Linden Group Corp (Cedar Knolls, US). The FDA issued a Cleared decision on February 25, 2016 after a review of 20 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 The Linden Group Corp devices

FDA 510(k) Submission Details - K160328

510(k) Number K160328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2016
Decision Date February 25, 2016
Days to Decision 20 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 107d · This submission: 20d
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 Consultant

Qubyx , Ltd.
MARC LEPPLA

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PGY Display, Diagnostic Radiology

All 134
Devices cleared under the same product code (PGY) and FDA review panel - the closest regulatory comparables to K160328.
CX50N, CX50YQS
K160351 · Wide Corporation · Apr 2016
CX20N(CX20PUX)
K160355 · Wide Corporation · Apr 2016
Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21
K160347 · Qingdao Hisense Medical Equipment Co., Ltd. · Mar 2016
2MP Color LCD Monitor, RadiForce RX250 and RX250-AR
K160247 · Eizo Corporation · Feb 2016
5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)
K160326 · Jvckenwood Corporation · Feb 2016
3MP Color LCD Monitor, RadiForce RX350
K153354 · Eizo Corporation · Jan 2016