ResolutionMD

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

510(k) Number

K161130 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• ResolutionMD, Version 1.3

  Class II

  FDA 510(k) K062164 Active Cleared 22 Sep 2006

• Resolutionmd Web

  Class II

  FDA 510(k) K120076 Active Cleared 19 Apr 2012

• Resolutionmd, Release 2.1

  Class II

  FDA 510(k) K082693 Active Cleared 23 Feb 2009

• Resolutionmd Cardiac Product Family, Model: Release 1.0

  Class II

  FDA 510(k) K071086 Active Cleared 1 Jun 2007

• ResolutionMD Mobile

  Class II

  FDA 510(k) K133508 Active Cleared 26 Mar 2014

• Resolutionmd Mobile Model Rmb-Mob-2X

  Class II

  FDA 510(k) K111346 Active Cleared 9 Sep 2011

See all devices from Calgary Scientific, Inc. →

• What types of environments is the ResolutionMD designed for, and how does it ensure safety in those settings?

  The ResolutionMD is specifically designed for use within MRI environments, where it provides precise, controlled movement and positioning. To ensure safety, it is built to comply with MRI safety standards, preventing interference or hazards that could disrupt imaging procedures or endanger patients. Its construction and materials are engineered to avoid electromagnetic interference with MRI equipment, making it a reliable choice for clinical settings where MRI compatibility is critical.

• Is the ResolutionMD intended for single-use or repeated use, and what maintenance considerations should be kept in mind?

  The ResolutionMD is supplied as a reusable device, meaning it is intended for repeated use across multiple procedures. To maintain its functionality and longevity, it must be handled and stored according to the manufacturer’s guidelines. Since it is not sterile, proper cleaning and maintenance protocols should be followed to ensure reliability and safety during each use in MRI-compatible settings.

• What regulatory pathways has the ResolutionMD undergone, and how does this affect its use in clinical settings?

  The ResolutionMD has undergone FDA 510(k) clearance (K161130) and is authorized under the Medical Device Regulation (MDR). Its classification as *Substantially Equivalent* by the FDA’s Radiology Advisory Committee (RA) confirms it meets established safety and performance standards for linear positioning devices in MRI environments. Clinicians can rely on this regulatory backing to ensure the device adheres to industry best practices for use in radiology procedures.

• How does the ResolutionMD help improve efficiency during MRI procedures, and who might benefit most from its use?

  The ResolutionMD enhances procedural efficiency by reducing the need for manual adjustments during MRI scans, minimizing operator fatigue and improving precision in patient or equipment alignment. Clinicians and technicians performing repetitive positioning tasks—such as radiologists, MRI technologists, or surgical teams—will benefit most from its controlled movement, leading to faster, more accurate imaging and smoother workflows in MRI-compatible settings.