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Sigma

by Instrumentarium Imaging, Inc.

510(k) K001928

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 NumberK001928 Date2 Aug 2000ClearedStatusActive

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  • Withdrawn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
MUH
Device Class
Class II
Regulation
21 CFR Part 872.1800
Advisory Committee
Dental
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 Sigma is a digital extraoral source X-ray system. It is designed for use in dental imaging applications.

This device is manufactured by Instrumentarium Imaging, Inc. and received FDA 510(k) clearance on August 2, 2000, under the reference number K001928.

Other devices from Instrumentarium Imaging, Inc.

See all devices from Instrumentarium Imaging, 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 primary use of the Sigma system?

    The Sigma is a digital extraoral source X-ray system specifically designed for use in dental imaging applications.

  • Who is the manufacturer of this device?

    The Sigma system is manufactured by Instrumentarium Imaging, Inc., located in Milwaukee, Wisconsin.

  • What is the regulatory status of the Sigma system?

    The Sigma system received FDA 510(k) clearance on August 2, 2000, under the reference number K001928.