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Pantos, Models: Pantos 16, and Pantos Dg

by Blue X Imaging Srl

510(k) K031801

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 NumberK031801 Date11 Sep 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  • Withdrawn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
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 Pantos, models Pantos 16 and Pantos DG, is an extraoral digital X-ray system. It is designed to capture radiographic images for dental diagnostic purposes.

This device is manufactured by Blue X Imaging Srl and has received FDA 510(k) clearance. It is classified under regulation number 872.1800 for use in dental clinical settings.

Other devices from Blue X Imaging Srl

  • IntraOs 70

    Class II

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 purpose of the Pantos X-ray system?

    The Pantos, including models Pantos 16 and Pantos DG, is an extraoral digital X-ray system specifically designed to capture radiographic images for dental diagnostic purposes.

  • Which models are available under the Pantos product line?

    The product line currently consists of two specific models: the Pantos 16 and the Pantos DG. Both models are manufactured by Blue X Imaging Srl and are intended for use in dental clinical settings.

  • What is the regulatory status of the Pantos system?

    The Pantos system has received FDA 510(k) clearance. It is classified under regulation number 872.1800, which pertains to extraoral source X-ray systems used in dental clinical environments.