Cleared Abbreviated

K211491 - RadiForce RX370

K211491 is the FDA 510(k) clearance for RadiForce RX370 by Eizo Corporation. It is a Class 2 Radiology device (product code PGY) cleared through the Abbreviated 510(k) pathway after a 60-day FDA review.

K211491 · Eizo Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2021
Decision
60d
Days
Class 2
Risk

K211491 is an FDA 510(k) clearance for the RadiForce RX370. Classified as Display, Diagnostic Radiology (product code PGY), Class II - Special Controls.

Submitted by Eizo Corporation (Hakusan, JP). The FDA issued a Cleared decision on July 12, 2021 after a review of 60 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Eizo Corporation devices

Submission Details

510(k) Number K211491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2021
Decision Date July 12, 2021
Days to Decision 60 days
Submission Type Abbreviated
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
47d faster than avg
Panel avg: 107d · This submission: 60d
Pathway characteristics
Standards-based clearance path.

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 K211491.
C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor
K212231 · Nanjing Jusha Display Technology Co., Ltd. · Mar 2022
6MP Color LCD Monitor CL-S600
K212985 · Jvckenwood Corporation · Dec 2021
21HQ513D
K212295 · Lg Electronics.Inc · Dec 2021
12MP Color Digital Mammography LCD Monitor CL-S1200
K203733 · Jvckenwood Corporation · Jun 2021
2MP Monochrome LCD Monitor MS-S200
K210345 · Jvckenwood Corporation · Apr 2021
CX30N (CX30PQX)
K210493 · Wide Corporation · Apr 2021