Cleared Traditional

6MP Color LCD Monitor (C61W+) (K182291) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182291 · Shenzhen Beacon Display Technology Co., Ltd. · Radiology device
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Nov 2018
Decision
89d
Days
Class 2
Risk

K182291 is an FDA 510(k) clearance for the 6MP Color LCD Monitor (C61W+). 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 November 20, 2018 after a review of 89 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

Submission Details

510(k) Number K182291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2018
Decision Date November 20, 2018
Days to Decision 89 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
18d faster than avg
Panel avg: 107d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 74
Devices cleared under the same product code (PGY) and FDA review panel - the closest regulatory comparables to K182291.
JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD Monitor
K183498 · Nanjing Jusha Display Technology Co., Ltd. · Feb 2019
JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor
K183499 · Nanjing Jusha Display Technology Co., Ltd. · Feb 2019
JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD Monitor
K183497 · Nanjing Jusha Display Technology Co., Ltd. · Jan 2019
RadiForce RX360, RX360-AR
K182591 · Eizo Corporation · Oct 2018
2MP Color LCD Monitor CL-R211
K182539 · Jvckenwood Corporation · Oct 2018
RadiForce GX560, GX560-AR
K181609 · Eizo Corporation · Aug 2018