Skip to content

Video Enhancement Unit

by Perkins Mfg. Co.

510(k) K954222

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 NumberK954222 Date8 Dec 1995ClearedStatusActive

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  • Withdrawn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 Video Enhancement Unit is a medical imaging device classified under the product code LLZ, designed to improve the quality and clarity of video signals in radiology procedures. It enhances visual output for diagnostic imaging, ensuring better contrast and detail for fluoroscopic and radiographic studies.

This device is intended for use in radiology settings and has received FDA 510(k) clearance under the Traditional pathway, classified as substantially equivalent. Supplied as a reusable medical device, it is regulated under the Radiology advisory committee and requires adherence to standard medical device safety and performance standards. No specific sterility or single-use designation is noted in the regulatory data.

Other devices from Perkins Mfg. Co.

See all devices from Perkins Mfg. Co. →

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 Video Enhancement Unit used for?

    The Video Enhancement Unit is designed to improve the quality and clarity of video signals in radiology procedures, enhancing visual output for better contrast and detail in fluoroscopic and radiographic studies.

  • Is the Video Enhancement Unit a single-use or reusable device?

    The Video Enhancement Unit is supplied as a reusable medical device, requiring adherence to standard medical device safety and performance standards for repeated use in clinical settings.

  • What regulatory approvals does the Video Enhancement Unit have?

    The device has received FDA 510(k) clearance under the Traditional pathway, classified as substantially equivalent, and is regulated under the Radiology advisory committee.

  • What are the specifications of the Video Enhancement Unit?

    The Video Enhancement Unit is classified under product code LLZ, received FDA clearance on December 8, 1995 (K954222), and is manufactured by Perkins Mfg. Co. in Dallas, Texas.