Skip to content

G.E. 48-4 Ceiling Tubehanger

by Electromek Diagnostic Systems, Inc.

510(k) K902791

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 NumberK902791 Date29 Oct 1990ClearedStatusActive

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  • Withdrawn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, 26 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 G.E. 48-4 Ceiling Tubehanger is a stationary X-ray system intended for diagnostic imaging. It is classified as a Class II medical device under regulation number 892.1680 and falls within the radiology medical specialty.

It received FDA 510(k) clearance (K902791) on October 29, 1990, as substantially equivalent to a predicate device. The device is manufactured by Electromek Diagnostic Systems, Inc., and is assigned product code KPR.

Other devices from Electromek Diagnostic Systems, Inc.

See all devices from Electromek Diagnostic Systems, Inc. →