Cleared Traditional

K200161 - 3MP Monochrome Digital Mammography LCD ...

K200161 is the FDA 510(k) clearance for 3MP Monochrome Digital Mammography LCD ... by Jvckenwood Corporation. It is a Class 2 Radiology device (product code PGY) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K200161 · Jvckenwood Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
30d
Days
Class 2
Risk

K200161 is an FDA 510(k) clearance for the 3MP Monochrome Digital Mammography LCD Monitor MS-S300. Classified as Display, Diagnostic Radiology (product code PGY), Class II - Special Controls.

Submitted by Jvckenwood Corporation (Yokohama, JP). The FDA issued a Cleared decision on February 21, 2020 after a review of 30 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 Jvckenwood Corporation devices

Submission Details

510(k) Number K200161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2020
Decision Date February 21, 2020
Days to Decision 30 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
77d faster than avg
Panel avg: 107d · This submission: 30d
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 K200161.
RadiForce RX1270, RadiForce RX1270-AR
K200485 · Eizo Corporation · Mar 2020
OptikView GUP2103CMI
K191705 · The Linden Group Corp · Mar 2020
32HL512D
K192925 · Lg Electronics.Inc · Mar 2020
21HK512D
K191864 · Lg Electronics.Inc · Dec 2019
Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)
K191845 · Barco N.V. · Sep 2019
5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500
K191137 · Jvckenwood Corporation · Jul 2019