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Orthoview

by Omsbar, Ltd.

510(k) K032401

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 NumberK032401 Date14 Aug 2003ClearedStatusActive

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  • Withdrawn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
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 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 Orthoview is a Class II X-ray system. It is manufactured by Omsbar, Ltd. The device is used in radiology.

The Orthoview is supplied with FDA 510K authorizations. It has a product code of LLZ and was cleared under K-number K032401 in 2003. The device is intended for use in a radiology setting.

Questions

AI-generated answers, 1 Oct 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 Orthoview used for?

    The Orthoview is used in radiology settings, indicating its purpose is to produce X-ray images for diagnostic purposes.

  • Is the Orthoview a single-use device?

    The device description does not specify if the Orthoview is for single-use or reuse, suggesting it may be designed for repeated use in a radiology setting.

  • What authorizations does the Orthoview have?

    The Orthoview has FDA 510K authorization, specifically cleared under K-number K032401 in 2003, indicating it has met certain regulatory requirements.