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ResolutionMD, Version 1.3

by Calgary Scientific, Inc.

510(k) K062164

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 NumberK062164 Date22 Sep 2006ClearedStatusActive

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  • Withdrawn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, 26 Sep 2026

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

ResolutionMD, Version 1.3 is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.

The device is supplied as software for use in radiology settings. It received FDA 510(k) clearance under K-number K062164 in 2006 as substantially equivalent to a predicate device. It is intended for use with general purpose computing hardware and does not include hardware components.

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Questions

AI-generated answers, 26 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 ResolutionMD Version 1.3 used for?

    ResolutionMD Version 1.3 is used for the display and 3D visualization of medical image data, including communication, storage, processing, rendering, and display of DICOM 3.0 compliant images from sources such as CT and MRI in radiology settings.

  • How is ResolutionMD Version 1.3 supplied and what hardware does it require?

    ResolutionMD Version 1.3 is supplied as software only and is designed to run on general purpose computing hardware; it does not include any hardware components and relies on existing computing infrastructure for operation.

  • Is ResolutionMD Version 1.3 intended for single-use or reuse in clinical environments?

    ResolutionMD Version 1.3 is reusable software intended for ongoing use in radiology settings, as it supports continuous storage, processing, and display of medical images over time without consumption or degradation from use.