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Sharp View Image Enhancement System

by Context Vision AB

510(k) K024028

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 NumberK024028 Date24 Jan 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  • Withdrawn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
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 Sharp View Image Enhancement System is a Class II X-ray system manufactured by Context Vision AB. It is designed for transfer, storage, enhancement, and viewing of medical images.

The device is used in radiology settings and is intended for use by qualified/trained technologists. It received FDA 510(k) clearance on January 24, 2003, with product code LLZ and model number K024028.

Other devices from Context Vision AB

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 Sharp View Image Enhancement System used for?

    The Sharp View Image Enhancement System is designed for transfer, storage, enhancement, and viewing of medical images in radiology settings. It is intended for use by qualified/trained technologists to improve image quality and diagnostic capabilities.

  • What are the specifications and regulatory status of the Sharp View Image Enhancement System?

    The Sharp View Image Enhancement System is a Class II X-ray system that received FDA 510(k) clearance on January 24, 2003. It has product code LLZ and model number K024028, and was determined to be substantially equivalent to predicate devices.

  • How is the Sharp View Image Enhancement System supplied and what are its storage requirements?

    The device is supplied as a complete system for medical image processing. While specific storage requirements aren't detailed in the provided information, as a medical electronic device, it should be stored in a controlled environment to maintain optimal performance and longevity.

  • Is the Sharp View Image Enhancement System reusable or single-use?

    The Sharp View Image Enhancement System is an electronic system designed for repeated use in medical imaging. It is not a disposable device but requires proper maintenance and calibration to ensure consistent performance and image quality over time.