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Instant-X, Models 1713 & 128

by Ann Arbor Digital Devices

510(k) K042791

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 NumberK042791 Date1 Jul 2005ClearedStatusActive

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  • Withdrawn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
MQB
Device Class
Class II
Regulation
21 CFR Part 892.1680
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

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

The Instant-X, Models 1713 & 128, is a Solid State X-Ray Imager (Flat Panel/Digital Imager). This device captures and converts X-ray signals into digital radiographic images, replacing traditional film-based systems. It functions as a direct replacement for analog film in diagnostic radiology, providing high-resolution digital outputs for clinical evaluation. The imager is designed for use in radiology settings to facilitate immediate image review and decision-making by physicians.

These models are intended for use in clinical radiology settings and are supplied as reusable medical devices. They are classified as Class II under FDA regulation 892.1680 and have received FDA 510(k) clearance under the Traditional pathway. The devices are not single-use and require proper maintenance and calibration to ensure accurate imaging performance. Storage and handling must comply with manufacturer guidelines to preserve functionality and image quality.