Skip to content

SCX Information Management System

by General Electric Co.

510(k) K870400

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 NumberK870400 Date18 Jun 1987ClearedStatusActive

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  • Withdrawn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, 6 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 SCX Information Management System is a Class II X-ray system designed for use in radiology. It is a stationary device that manages information related to X-ray imaging.

The device is supplied as a system and is intended for single-use applications. It is not specified as reusable, sterile, or MRI-safe. Storage requirements are not detailed in the provided data. The device is regulated under FDA 510(k) clearance (K870400) and has an advisory committee designation of Radiology (RA).

Other devices from General Electric Co.

See all devices from General Electric Co. →