Cleared Traditional

K940540 - VELO ACE

K940540 is an FDA 510(k) clearance for VELO ACE, manufactured by Emix U.S.A., Inc.. The device is a Class 2 Radiology device with product code IXW cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K940540 · Emix U.S.A., Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Jul 1994
Decision
161d
Days
Class 2
Risk

K940540 is an FDA 510(k) clearance for the VELO ACE. Classified as Processor, Radiographic-film, Automatic (product code IXW), Class II - Special Controls.

Submitted by Emix U.S.A., Inc. (King Of Prussia, US). The FDA issued a Cleared decision on July 18, 1994 after a review of 161 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1900 - 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 Emix U.S.A., Inc. devices

FDA 510(k) Submission Details - K940540

510(k) Number K940540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1994
Decision Date July 18, 1994
Days to Decision 161 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 107d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXW Device Classification - Class 2, Special Controls

Product Code IXW Processor, Radiographic-film, Automatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1900
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 - IXW Processor, Radiographic-film, Automatic

All 54
Devices cleared under the same product code (IXW) and FDA review panel - the closest regulatory comparables to K940540.
KODAK X-OMAT 3000 RA PROCESSOR
K951396 · Eastman Kodak Company · May 1995
KODAK X-OMAT 5000 RA PROCESSOR
K951397 · Eastman Kodak Company · May 1995
FUJI COMPUTED RADIOGRAPHY SYSTEMS
K944046 · Fujifilm Medical System U.S.A., Inc. · May 1995
3M XP-2000 X-RAY FILM PROCESSOR
K940558 · 3M Company · Mar 1994
KODAK X-OMAT M43A, M43, & CLINIC 1 PROCESSORS
K934350 · Eastman Kodak Company · Mar 1994
FUJI MEDICAL FILM PROCESSOR FPM2800
K935957 · Fujifilm Medical System U.S.A., Inc. · Jan 1994