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OMNIVISION

by Modern Module, Inc.

510(k) K110040

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 NumberK110040 Date26 Jan 2011ClearedStatusActive

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  • Withdrawn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, 22 Sep 2026

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

OMNIVISION is a medical imaging system with a modular architecture consisting of a basic application viewer for image viewing and processing, image storage and communication, along with additional modules for database management, image acquisition, and printing. The system conforms to the DICOM (Digital Image and Communications in Medicine) standard.

OMNIVISION is supplied as a modular system and is not described as single-use or reusable in the provided data. The device has received FDA 510(k) clearance with the product code LLZ and K-number K110040. No specific sizes, sterility information, or MRI safety details are provided in the device data.

Questions

AI-generated answers, 22 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 OMNIVISION medical imaging system used for?

    OMNIVISION is a medical imaging system with a modular architecture that includes an application viewer for image viewing and processing, image storage and communication, along with additional modules for database management, image acquisition, and printing.

  • Is OMNIVISION a single-use or reusable device?

    The device is supplied as a modular system and is not described as single-use or reusable in the provided data.

  • What regulatory approvals has OMNIVISION received?

    OMNIVISION has received FDA 510(k) clearance with the product code LLZ and K-number K110040, determined to be substantially equivalent to predicate devices.

  • What standards does OMNIVISION conform to?

    The system conforms to the DICOM (Digital Image and Communications in Medicine) standard, ensuring compatibility with other medical imaging systems and devices.