Cleared Traditional

Hisense LCD monitor HMD2G21S, HMD3G21S (K222132) - FDA 510(k) Clearance

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

K222132 · Qingdao Hisense Medical Equipment Co., Ltd. · Radiology device
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Nov 2022
Decision
112d
Days
Class 2
Risk

K222132 is an FDA 510(k) clearance for the Hisense LCD monitor HMD2G21S, HMD3G21S. Classified as Display, Diagnostic Radiology (product code PGY), Class II - Special Controls.

Submitted by Qingdao Hisense Medical Equipment Co., Ltd. (Qingdao, CN). The FDA issued a Cleared decision on November 8, 2022 after a review of 112 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Qingdao Hisense Medical Equipment Co., Ltd. devices

Submission Details

510(k) Number K222132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2022
Decision Date November 08, 2022
Days to Decision 112 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
5d slower than avg
Panel avg: 107d · This submission: 112d
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
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