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ResolutionMD Mobile

by Calgary Scientific, Inc.

510(k) K133508

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 NumberK133508 Date26 Mar 2014ClearedStatusActive

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  • Withdrawn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.

ResolutionMD Mobile is a medical device software platform designed for the visualization and sharing of 2D and 3D medical images. It enables healthcare professionals to view, collaborate on, and diagnose from medical imaging data using mobile devices.

The device is supplied as a software application for use in healthcare settings, supporting secure access to patient images and reports from various computers and mobile devices. It is intended for use by authorized healthcare professionals and operates under FDA 510(k) clearance (K133508) with product code LLZ, classified under the Radiology advisory committee.

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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 ResolutionMD Mobile used for?

    ResolutionMD Mobile is used for the visualization and sharing of 2D and 3D medical images, allowing healthcare professionals to view, collaborate on, and diagnose from medical imaging data using mobile devices in healthcare settings.

  • How is ResolutionMD Mobile supplied and accessed?

    ResolutionMD Mobile is supplied as a software application that supports secure access to patient images and reports from various computers and mobile devices, intended for use by authorized healthcare professionals in healthcare settings.

  • Is ResolutionMD Mobile a single-use or reusable device?

    ResolutionMD Mobile is a reusable software platform, as it is designed for ongoing use by healthcare professionals to access and share medical imaging data across multiple sessions and devices, not for single-use disposal.

  • What regulatory pathway was used for ResolutionMD Mobile?

    ResolutionMD Mobile received FDA 510(k) clearance under submission K133508, with product code LLZ, and was classified under the Radiology advisory committee as substantially equivalent to a predicate device.