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Alara T210 Computed Radiography System

by Alara, Inc.

510(k) K102479

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 NumberK102479 Date2 Jun 2011ClearedStatusActive

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  • Withdrawn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
MQB
Device Class
Class II
Regulation
21 CFR Part 892.1680
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 Alara T210 Computed Radiography System is a Class II X-ray system used for generating radiographic images of human anatomy. It is designed to replace radiographic film-screen systems in all general-purpose diagnostic procedures.

The system is manufactured by Alara, Inc. and is supplied as a reusable device. It has received FDA 510(k) clearance under K-number K102479 in 2011 for use in radiology. The device is regulated under product code MQB and regulation number 892.1680.

Other devices from Alara, Inc.

Questions

AI-generated answers, 28 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 Alara T210 Computed Radiography System used for?

    The Alara T210 Computed Radiography System is used for generating radiographic images of human anatomy in general-purpose diagnostic procedures, designed to replace traditional radiographic film-screen systems in radiology settings.

  • Is the Alara T210 Computed Radiography System reusable or single-use?

    The Alara T210 Computed Radiography System is supplied as a reusable device, meaning it is designed for multiple uses after appropriate cleaning and maintenance between procedures, not for single-use disposal.

  • What regulatory clearance does the Alara T210 Computed Radiography System have?

    The Alara T210 Computed Radiography System received FDA 510(k) clearance under K-number K102479 in 2011, confirming its substantial equivalence to a legally marketed predicate device for use in radiology.