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IMAGE-X 70 Intraoral X-Ray System

by Afp Imaging Corp.

510(k) K930761

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 NumberK930761 Date25 May 1993ClearedStatusActive

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  • Withdrawn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
EAP
Device Class
Class II
Regulation
21 CFR Part 872.1810
Advisory Committee
Dental
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 IMAGE-X 70 Intraoral X-Ray System is a dental imaging device designed to capture intraoral radiographs, including standard bitewings and FMX series. It features a 360-degree horizontal rotation, precise tube-head positioning, an independent spring system, and a 0.7mm focal spot. The system includes an articulating arm, soft-touch membrane function buttons, and a large four-figure display that shows exposure time in hundredths of a second.

The device is intended for use in dental settings and is supplied as a complete intraoral X-ray system. It is powered on and functional at the time of listing, though it may have been previously used in clinical or veterinary environments. The system is sold as-is with no warranty, and shipping is not included; buyers must coordinate freight separately. It is regulated under FDA 510(k) clearance with product code EAP and is classified as a Class II device.

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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 IMAGE-X 70 used for?

    The IMAGE-X 70 is designed for capturing intraoral radiographs in dental settings, including standard bitewings and full-mouth (FMX) series. It is not intended for extraoral or panoramic imaging.

  • How is the IMAGE-X 70 supplied?

    It is sold as a complete intraoral X-ray system, including the tube head, articulating arm, control panel, and display. The unit is powered on and functional at the time of listing, though it may have prior clinical or veterinary use.

  • Is the IMAGE-X 70 sold with a warranty?

    No, the IMAGE-X 70 is sold as-is with no warranty. Buyers assume all responsibility for performance, maintenance, and any required servicing after purchase.

  • What are the key specifications of the IMAGE-X 70?

    It features a 360-degree horizontal rotation, precise tube-head positioning, an independent spring system, a 0.7mm focal spot, soft-touch membrane buttons, and a four-figure display showing exposure time in hundredths of a second.

  • Who coordinates shipping for the IMAGE-X 70?

    Shipping is not included with the purchase. Buyers must coordinate freight separately and are responsible for all transport, handling, and installation costs.