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PXI (Personal X-Ray Imager) 512

by Oklahoma Digital Technologies, Inc.

510(k) K881993

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 NumberK881993 Date19 Sep 1988ClearedStatusActive

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The PXI (Personal X-Ray Imager) 512 is a Class II X-ray system manufactured by Oklahoma Digital Technologies, Inc. It is designed for use in radiology departments for imaging purposes. The device model number is 512 and it has been assigned the product code LLZ.

The PXI (Personal X-Ray Imager) 512 received FDA 510(k) clearance with number K881993 on September 19, 1988, and was determined to be substantially equivalent. It is manufactured in Oklahoma City, OK, and is intended for use in radiology settings. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided.

Questions

AI-generated answers, 1 Oct 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 PXI Personal X-Ray Imager 512 used for?

    The PXI Personal X-Ray Imager 512 is designed for use in radiology departments for imaging purposes. It is a Class II X-ray system that helps capture X-ray images for diagnostic procedures.

  • Is the PXI Personal X-Ray Imager 512 a single-use device?

    The device is not specified as single-use or reusable in the available information. Users should consult the manufacturer's instructions for specific guidance on usage and disposal protocols.

  • What regulatory approvals does the PXI Personal X-Ray Imager 512 have?

    The PXI Personal X-Ray Imager 512 received FDA 510(k) clearance with number K881993 on September 19, 1988, and was determined to be substantially equivalent. It is manufactured in Oklahoma City, OK.

  • What are the specifications of the PXI Personal X-Ray Imager 512?

    The device model number is 512 and has been assigned the product code LLZ. It is a Class II X-ray system intended for use in radiology settings, though specific technical measurements or imaging capabilities are not provided in the available data.