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ResolutionMD Mobile 3.1 Model RMD-MOB-31

by Calgary Scientific, Inc.

510(k) K123186

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K123186↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK123186 Date14 Mar 2013ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 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, 18 Sep 2026

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

The ResolutionMD Mobile 3.1 Model RMD-MOB-31 is a Class II mobile X-ray imaging system designed for wireless access and viewing of medical images. It functions as a Picture Archiving and Communication System (PACS) with DICOM 3.0-compliant compatibility, enabling server-side processing, reformatting, and transmission of CT and MR images to mobile devices.

This device is intended for use in radiology settings, providing radiologists, physicians, and technologists with the ability to display images and reports on mobile screens. Supplied as a reusable system, it adheres to FDA 510(k) clearance (K123186) and EU MDR regulations, with no specific sterility or single-use requirements noted. The system operates within standard radiology environments and does not have documented MRI safety restrictions.

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Questions

AI-generated answers, 18 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 types of medical images can the ResolutionMD Mobile 3.1 display and how does it handle them?

    The ResolutionMD Mobile 3.1 is designed to display and process CT and MR images via its DICOM 3.0-compliant system. It supports server-side processing, reformatting, and wireless transmission of these images to mobile devices, enabling radiologists, physicians, and technologists to view them on their screens in radiology settings.

  • Is this device intended for use in MRI environments, or are there any safety restrictions to consider?

    The ResolutionMD Mobile 3.1 does not have documented MRI safety restrictions, meaning it is not explicitly designed for use within MRI environments. However, since it is a wireless X-ray imaging system, standard radiology safety protocols should still be followed to avoid interference or hazards in any clinical setting.

  • How is the ResolutionMD Mobile 3.1 supplied, and does it require any special handling like sterilization?

    The device is supplied as a reusable system, meaning it is not single-use or sterile. Since it is not intended for direct patient contact or sterile procedures, no special sterilization or single-use requirements apply. Standard maintenance and cleaning protocols for medical imaging equipment should be followed.

  • What regulatory pathways does this device follow, and where was it cleared or authorized?

    The ResolutionMD Mobile 3.1 received FDA 510(k) clearance (K123186) under the Traditional pathway, with a decision date of March 14, 2013. It is also authorized under EU MDR (Medical Device Regulation). The device was filed under the Radiology product code (LLZ) and reviewed by the Radiology (RA) Advisory Committee.