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OEC 901

by Baldwin

510(k) K942841

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 NumberK942841 Date9 Aug 1994ClearedStatusActive

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  • Withdrawn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
JAA
Device Class
Class II
Regulation
21 CFR Part 892.1650
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 OEC 901 is a Class II fluoroscopic system, image-intensified, used in radiology. It is designed for X-ray imaging procedures in medical settings.

The device is manufactured by Baldwin and received FDA 510(k) clearance on August 9, 1994, with the K number K942841. It is regulated under product code JAA and regulation number 892.1650. The device is supplied in various sizes as indicated by the multiple registration numbers associated with it.

Questions

AI-generated answers, 27 Sep 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 OEC 901 used for?

    The OEC 901 is a Class II fluoroscopic system, image-intensified, designed for X-ray imaging procedures in medical radiology settings. It provides enhanced imaging capabilities for various diagnostic procedures.

  • How is the OEC 901 supplied?

    The device is supplied in various sizes as indicated by the multiple registration numbers associated with it. It is manufactured by Baldwin and distributed through their Cleveland facility at 1441 E. 17th St.

  • What is the regulatory status of the OEC 901?

    The OEC 901 received FDA 510(k) clearance on August 9, 1994, with K number K942841. It is regulated under product code JAA and regulation number 892.1650, classified as substantially equivalent to predicate devices.

  • Is the OEC 901 reusable or single-use?

    The device is a fluoroscopic system designed for repeated use in medical settings. It is not a single-use device but requires proper maintenance and calibration according to manufacturer specifications to ensure continued safe and effective operation.