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FDR Cross DR-XD 3000

by Fujifilm Corporation

510(k) K212956

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 NumberK212956 Date8 Nov 2021ClearedStatusActive

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  • Withdrawn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
OWB
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 FDR Cross DR-XD 3000 is an interventional fluoroscopic X-ray system designed for both fluoroscopic imaging and static X-ray image acquisition. It features a tilting tube head and a removable detector design to provide imaging flexibility and efficiency.

This system utilizes interchangeable glass-free flat panel detectors available in 17x17 inch, 14x17 inch, and 10x12 inch sizes. The device is authorized under FDA 510K clearance.

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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 function of the FDR Cross DR-XD 3000?

    This device is an interventional fluoroscopic X-ray system designed to perform both fluoroscopic imaging and the acquisition of static X-ray images.

  • What detector sizes are available for this system?

    The system utilizes interchangeable glass-free flat panel detectors, which are available in three distinct sizes: 17x17 inches, 14x17 inches, and 10x12 inches.

  • What design features contribute to the system's imaging flexibility?

    The system is designed with a tilting tube head and a removable detector configuration, which allows for greater efficiency and flexibility during imaging procedures.

  • Is this device authorized for use?

    Yes, the FDR Cross DR-XD 3000 is authorized under FDA 510K clearance.