Cleared Traditional

K221567 - LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) (FDA 510(k) Clearance)

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

K221567 · Qingdao Hisense Medical Equipment Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2022
Decision
56d
Days
Class 2
Risk

K221567 is an FDA 510(k) clearance for the LCD monitor (HMD3C21S), LCD monitor (HMD5G21S). 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 July 26, 2022 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

Submission Details

510(k) Number K221567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2022
Decision Date July 26, 2022
Days to Decision 56 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
51d faster than avg
Panel avg: 107d · This submission: 56d
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 Consultant

Shenzhen Joyantech Consulting Co., Ltd.
Hanson Chen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PGY Display, Diagnostic Radiology

All 133
Devices cleared under the same product code (PGY) and FDA review panel - the closest regulatory comparables to K221567.
LCD Monitor (CL1902A, CL2103F)
K252780 · Shenzhen Beacon Display Technology Co., Ltd. · Dec 2025
LCD Monitor (C1216W, C822W, C821W)
K253242 · Shenzhen Beacon Display Technology Co., Ltd. · Oct 2025
RadiForce GX570
K252030 · Eizo Corporation · Aug 2025
RadiForce RX570
K243221 · Eizo Corporation · Nov 2024
LCD Monitors C310S, G310S, C316S, G316S, C616W
K243031 · Shenzhen Beacon Display Technology Co., Ltd. · Oct 2024
Coronis OneLook
K242008 · Barco N.V. · Aug 2024