Cleared Traditional

K172815 - 2MP LCD Monitor (G22S+

K172815 is an FDA 510(k) clearance for 2MP LCD Monitor (G22S+, 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 39-day FDA review.

K172815 · Shenzhen Beacon Display Technology Co., Ltd. · Radiology device
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Oct 2017
Decision
39d
Days
Class 2
Risk

K172815 is an FDA 510(k) clearance for the 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+). 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 October 27, 2017 after a review of 39 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 - K172815

510(k) Number K172815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2017
Decision Date October 27, 2017
Days to Decision 39 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
68d faster than avg
Panel avg: 107d · This submission: 39d
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 K172815.
RadiForce MX194
K180961 · Eizo Corporation · May 2018
2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300
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RadiForce RX560, RX560-AR
K172738 · Eizo Corporation · Nov 2017
Nio Color 2MP (MDNC-2123)
K171812 · Barco N.V. · Jul 2017
RadiForce MX315W
K170949 · Eizo Corporation · Apr 2017
Nio Color 3MP (MDNC-3421)
K170837 · Barco N.V. · Apr 2017