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Digital Image Acquisition System

by International Imaging Electronics

510(k) K950330

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK950330 Date7 May 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IYO
Device Class
Class II
Regulation
21 CFR Part 892.1560
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

This device is a Digital Image Acquisition System, classified under the nomenclature for medical imaging devices designed to capture and digitise radiographic images for diagnostic purposes. It functions as a standalone unit to convert analog or digital signals from imaging modalities into digital format, enabling storage, transmission, and post-processing for clinical review.

The system is intended for use in radiology departments and clinical imaging settings, where it interfaces with X-ray, fluoroscopy, or other imaging modalities to acquire and digitise images. Supplied as a reusable device, it requires proper calibration and maintenance in accordance with manufacturer guidelines. Authorised under FDA 510(k) clearance (K950330), it adheres to regulatory standards for radiology equipment, ensuring compatibility with existing diagnostic workflows.

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Questions

AI-generated answers, 19 Sep 2026

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

  • What types of imaging modalities can this Digital Image Acquisition System interface with for capturing and digitizing images?

    This system is designed to interface with X-ray and fluoroscopy modalities, as well as other imaging modalities that generate analog or digital signals. It converts these signals into a digital format, enabling seamless integration into radiology workflows for storage, transmission, and further analysis.

  • Is this device intended for single-use or reusable applications in a clinical setting?

    The Digital Image Acquisition System is supplied as a reusable device. It requires proper calibration and maintenance to ensure consistent performance and reliability in radiology departments and clinical imaging settings.

  • How was the regulatory pathway for this device determined, and what does that mean for its use?

    This device was cleared through the FDA’s 510(k) process, specifically under a Traditional clearance route with a Substantially Equivalent determination by the Radiology (RA) Advisory Committee. This means it was compared to a legally marketed predicate device and deemed equivalent in safety and effectiveness, allowing it to enter the market with established regulatory oversight.

  • What kind of maintenance or calibration does this system require to function properly?

    Since this is a reusable device, it must be regularly calibrated and maintained according to the manufacturer’s guidelines to ensure accurate image acquisition and digitization. Proper upkeep is critical for maintaining compatibility with imaging modalities and preserving diagnostic workflow efficiency.