Cleared Traditional

K162527 - 8MP Color LCD Monitor (C81W+)

K162527 is an FDA 510(k) clearance for 8MP Color LCD Monitor (C81W+), manufactured by Shenzhen Beacon Display Technology Co., Ltd.. The device is a Class 2 Radiology device with product code PGY cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K162527 · Shenzhen Beacon Display Technology Co., Ltd. · Radiology device
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Sep 2016
Decision
21d
Days
Class 2
Risk

K162527 is an FDA 510(k) clearance for the 8MP Color LCD Monitor (C81W+). Classified as Display, Diagnostic Radiology (product code PGY), Class II - Special Controls.

Submitted by Shenzhen Beacon Display Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on September 30, 2016 after a review of 21 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 Shenzhen Beacon Display Technology Co., Ltd. devices

FDA 510(k) Submission Details - K162527

510(k) Number K162527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2016
Decision Date September 30, 2016
Days to Decision 21 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
86d faster than avg
Panel avg: 107d · This submission: 21d
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 112
Devices cleared under the same product code (PGY) and FDA review panel - the closest regulatory comparables to K162527.
Nio Color 3MP (MDNC-3421)
K170837 · Barco N.V. · Apr 2017
Nio Color 5.8MP (MDNC-6121)
K170476 · Barco N.V. · Mar 2017
6MP Color LCD Monitor, RadiForce RX660, RX660-AR
K163335 · Eizo Corporation · Dec 2016
5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR
K162497 · Eizo Corporation · Sep 2016
2MP Color LCD Monitor CCL214 (CL21214)
K161895 · Jvckenwood Corporation · Sep 2016
Mammo Tomosynthesis (MDMG-5221)
K161229 · Barco N.V. · May 2016