Cleared Traditional

K160347 - Hisense LDC monitor models HMD2G21/HMD3...

K160347 is an FDA 510(k) clearance for Hisense LDC monitor models HMD2G21/HMD3..., manufactured by Qingdao Hisense Medical Equipment Co., Ltd.. The device is a Class 2 Radiology device with product code PGY cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K160347 · Qingdao Hisense Medical Equipment Co., Ltd. · Radiology device
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Mar 2016
Decision
24d
Days
Class 2
Risk

K160347 is an FDA 510(k) clearance for the Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21. Classified as Display, Diagnostic Radiology (product code PGY), Class II - Special Controls.

Submitted by Qingdao Hisense Medical Equipment Co., Ltd. (Qing Dao, CN). The FDA issued a Cleared decision on March 3, 2016 after a review of 24 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 Qingdao Hisense Medical Equipment Co., Ltd. devices

FDA 510(k) Submission Details - K160347

510(k) Number K160347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2016
Decision Date March 03, 2016
Days to Decision 24 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
83d faster than avg
Panel avg: 107d · This submission: 24d
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 104
Devices cleared under the same product code (PGY) and FDA review panel - the closest regulatory comparables to K160347.
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
Mammo Tomosynthesis (MDMG-5221)
K161229 · Barco N.V. · May 2016
2MP Color LCD Monitor, RadiForce RX250 and RX250-AR
K160247 · Eizo Corporation · Feb 2016
3MP Color LCD Monitor, RadiForce RX350
K153354 · Eizo Corporation · Jan 2016
8MP Color LCD Monitor, RadiForce RX850, RX850-AR
K152713 · Eizo Corporation · Nov 2015