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Personal Digital Workstation (PDW); Film Digitizing Camera and Digital Workstation

by Maxxvision, LLC

510(k) K031372

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 NumberK031372 Date2 Jul 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  • Withdrawn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
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 892.2050
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 Personal Digital Workstation (PDW) is a film digitizing camera and digital workstation used for radiology applications. It converts analog film images into digital format for viewing and analysis.

The device is supplied by Maxxvision, LLC and has received FDA 510(k) clearance with K031372. It is intended for use in radiology settings and is not specified as single-use or reusable. No specific MRI safety information is provided in the data.

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 Personal Digital Workstation (PDW) used for?

    The PDW is a film digitizing camera and digital workstation designed for radiology applications. It converts analog film images into digital format for viewing and analysis in medical settings.

  • Is the PDW a single-use device or can it be reused?

    The device data does not specify whether the Personal Digital Workstation is single-use or reusable. This information should be obtained directly from the manufacturer, Maxxvision, LLC, for proper usage guidelines.

  • What regulatory approvals has the PDW received?

    The Personal Digital Workstation has received FDA 510(k) clearance with K031372. It was determined to be substantially equivalent to other legally marketed devices and is intended for use in radiology settings.

  • How is the PDW supplied?

    The Personal Digital Workstation is supplied by Maxxvision, LLC. For specific details regarding packaging, configuration, or accessories included with the device, direct contact with the manufacturer would provide the most accurate information.