Cleared Traditional

K152030 - Hisense 2MP/3MP LCD Monitor (HMD2C21/HM...

K152030 is an FDA 510(k) clearance for Hisense 2MP/3MP LCD Monitor (HMD2C21/HM..., 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 56-day FDA review.

K152030 · Qingdao Hisense Medical Equipment Co., Ltd. · Radiology device
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Sep 2015
Decision
56d
Days
Class 2
Risk

K152030 is an FDA 510(k) clearance for the Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21). 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 September 16, 2015 after a review of 56 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 - K152030

510(k) Number K152030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2015
Decision Date September 16, 2015
Days to Decision 56 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
51d faster than avg
Panel avg: 107d · This submission: 56d
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 K152030.
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JUSHA-C23C LCD Monitor
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JUSHA-C43 LCD Monitor
K151972 · Nanjing Jusha Display Technology Co., Ltd. · Sep 2015
5MP Monochrome LCD Monitor, RadiForce GX540
K151883 · Eizo Corporation · Jul 2015