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Oec 902, 901 Nasa Ii, Oec 902, 901 Nasa I Ccd C-Arm

by Imaging Services, Inc.

510(k) K955251

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 NumberK955251 Date12 Apr 1996ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 21 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 902, 901 Nasa Ii, Oec 902, 901 Nasa I Ccd C-Arm is an Image-Intensified Fluoroscopic X-Ray System, Mobile. It is classified as a Class II device with product code OXO. The device is substantially equivalent to other C-arm models, such as the OEC 901 and 902. It is used in the field of Radiology.

The device is supplied by Imaging Services, Inc. and has been cleared under FDA 510K with the number K955251. The device is regulated under the regulation number 892.1650. It is a mobile system, and its registration numbers include 3013099020, 3027339477, and 3003768277, among others.

Other devices from Imaging Services, Inc.

Questions

AI-generated answers, 21 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 902 C-Arm used for?

    The OEC 902 C-Arm is used in the field of Radiology for image-intensified fluoroscopic x-ray imaging.

  • Is the OEC 902 C-Arm a mobile system?

    Yes, the OEC 902 C-Arm is a mobile system, allowing for flexible use in various settings.

  • What is the regulatory status of the OEC 902 C-Arm?

    The OEC 902 C-Arm has been cleared under FDA 510K with the number K955251 and is regulated under the regulation number 892.1650.

  • What type of device is the OEC 902 C-Arm classified as?

    The OEC 902 C-Arm is classified as a Class II device with product code OXO.