Skip to content

Orthoscan TAU Mini C-Arm

by Orthoscan, Ltd. 2 variants

510(k) K183220

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 NumberK183220 Date21 Jun 2019ClearedStatusActive

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  • Withdrawn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
FDA applicant
Orthoscan, Inc.
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 Orthoscan TAU Mini C-Arm is an Image-Intensified Fluoroscopic X-Ray System, Mobile. It is substantially equivalent to other devices and is used in the field of Radiology.

The device is supplied with various features and is designed for use in medical settings. It has a small and lightweight form factor and is designed for pediatric use, with dose-saving features and improved articulation and arm design. The device is regulated under the regulation number 892.1650 and has been authorized by the FDA under the 510K clearance type.

Other devices from Orthoscan, Ltd.