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Velo Ace Automatic Radiographic-Film Processor

by Emix U.S.A., Inc.

510(k) K940540

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK940540 Date18 Jul 1994ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Velo Ace
510(k) Number
FDA Product Code
IXW
Device Class
Class II
Regulation
21 CFR Part 892.1900
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Velo Ace is an Automatic Radiographic-Film Processor (Device Class II), designed to develop and process radiographic films for diagnostic imaging. It automates the chemical processing steps—including development, fixation, and washing—required to produce clear radiographic images from exposed film. This device is intended for use in radiology departments to enhance workflow efficiency by reducing manual handling and processing time.

The Velo Ace is supplied as a reusable, non-sterile device intended for use in radiology settings. It operates under controlled environmental conditions and requires periodic maintenance, including chemical replenishment and equipment calibration. The processor adheres to FDA 510(k) clearance (K940540, Traditional Review, Substantially Equivalent) and is categorized under product code IXW for radiographic-film processing systems. No MRI safety or sterility claims are specified in the regulatory data.

Other devices from Emix U.S.A., Inc.

  • Lumix 70B

    Class II

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Velo Ace used for?

    The Velo Ace is an Automatic Radiographic-Film Processor designed to automate the chemical processing steps—development, fixation, and washing—of exposed radiographic films. This reduces manual handling and processing time in radiology departments, improving workflow efficiency for diagnostic imaging.

  • Is the Velo Ace reusable or single-use?

    The Velo Ace is a reusable device. It is intended for repeated use in radiology settings, with periodic maintenance—such as chemical replenishment and equipment calibration—required to ensure proper function and image quality.

  • What regulatory clearance does the Velo Ace hold?

    The Velo Ace holds FDA 510(k) clearance under the reference number K940540, classified as substantially equivalent through a traditional review process. It is categorized under product code IXW for radiographic-film processing systems.

  • Does the Velo Ace require sterility or special handling?

    The Velo Ace is non-sterile and does not require sterile handling. It is designed for use in controlled radiology environments where standard infection control practices apply. Sterility is not specified or claimed for this device.

  • How does the Velo Ace differ from manual film processing?

    Unlike manual processing, which involves multiple steps of chemical immersion and manual agitation, the Velo Ace automates these steps in a controlled sequence. This reduces processing time, minimizes human error, and enhances consistency in radiographic image quality, making it ideal for high-volume radiology departments.