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Imix Insight X-Ray Systems

by Imix Adr Finland OY

510(k) K073114

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 · Special NumberK073114 Date17 Jan 2008ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 22 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 IMIX INSIGHT X-RAY SYSTEMS is a Class II stationary X-ray system manufactured by Imix Adr Finland OY. It is designed for use in radiology departments for diagnostic imaging purposes. The system is classified under regulation number 892.1680 and has been cleared for use through the FDA 510(k) process.

The IMIX INSIGHT X-RAY SYSTEMS is supplied as a stationary system and is intended for single or multiple use depending on the specific configuration. The device has received FDA clearance with the K073114 number and is classified under product code KPR. It is manufactured by Imix Adr Finland OY and is regulated under the FDA's requirements for stationary X-ray systems.

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