Cleared Traditional

21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01) (K233336) - FDA 510(k) Clearance

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

K233336 · Acula Technology Corp. · Radiology device
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May 2024
Decision
235d
Days
Class 2
Risk

K233336 is an FDA 510(k) clearance for the 21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01). Classified as Display, Diagnostic Radiology (product code PGY), Class II - Special Controls.

Submitted by Acula Technology Corp. (Taoyuan, TW). The FDA issued a Cleared decision on May 21, 2024 after a review of 235 days - an extended review 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: 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 Acula Technology Corp. devices

Submission Details

510(k) Number K233336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2023
Decision Date May 21, 2024
Days to Decision 235 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
128d slower than avg
Panel avg: 107d · This submission: 235d
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
Devices cleared under the same product code (PGY) and FDA review panel - the closest regulatory comparables to K233336.
3MP Color LCD Monitor (CL-S301)
K241105 · Jvckenwood Corporation · Aug 2024
RadiForce RX670
K241441 · Eizo Corporation · Jul 2024
21.3” 5MP Color LCD Display UMD5-21B01
K241499 · Acula Technology Corp. · Jun 2024
LCD Monitors C310S, G310S, C316S, G316S, C616W
K240310 · Shenzhen Beacon Display Technology Co., Ltd. · Mar 2024
Medical Monitor (21HQ613D)
K240130 · Lg Electronics.Inc · Feb 2024
5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S)
K233897 · Shenzhen Beacon Display Technology Co., Ltd. · Feb 2024