Cleared Traditional

K183497 - JUSHA-M260G LCD Monitor

K183497 is the FDA 510(k) clearance for JUSHA-M260G LCD Monitor by Nanjing Jusha Display Technology Co., Ltd.. It is a Class 2 Radiology device (product code PGY) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K183497 · Nanjing Jusha Display Technology Co., Ltd. · Radiology device
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Jan 2019
Decision
29d
Days
Class 2
Risk

K183497 is an FDA 510(k) clearance for the JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD .... Classified as Display, Diagnostic Radiology (product code PGY), Class II - Special Controls.

Submitted by Nanjing Jusha Display Technology Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on January 15, 2019 after a review of 29 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 Nanjing Jusha Display Technology Co., Ltd. devices

Submission Details

510(k) Number K183497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2018
Decision Date January 15, 2019
Days to Decision 29 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
78d faster than avg
Panel avg: 107d · This submission: 29d
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 82
Devices cleared under the same product code (PGY) and FDA review panel - the closest regulatory comparables to K183497.
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6MP Color LCD Monitor (C61W+)
K182291 · Shenzhen Beacon Display Technology Co., Ltd. · Nov 2018
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