Instrumentarium MEGA4

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

510(k) Number

K915552 ↗

FDA Product Code

LNH

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Magnaview M.R.I. Versions 110FH & 110FM W/Cardiac

  Class II

  FDA 510(k) K896309 Active Cleared 12 Jan 1990

• Instrumentarium MEGA4 Ht

  Class II

  FDA 510(k) K924921 Active Cleared 17 May 1993

• Delta 32 and Delta 32 Tact

  Class II

  FDA 510(k) K002472 Active Cleared 29 Nov 2000

• Mega 4 Magnetic Resonance Imaging System

  Class II

  FDA 510(k) K902044 Active Cleared 23 Aug 1990

• Magnaview Mobile MRI Version 110 Fhm

  Class II

  FDA 510(k) K891543 Active Cleared 23 Jun 1989

• Instrumentarium MEGA4, Modification

  Class II

  FDA 510(k) K904528 Active Cleared 20 Nov 1990

See all devices from Instrumentarium Imaging, Inc. →

• What is the primary use of the Instrumentarium Mega4 in a clinical setting?

  The Instrumentarium Mega4 is a Nuclear Magnetic Resonance Imaging (MRI) system designed for radiology departments. It is used to generate detailed images of the body’s internal structures, aiding in the diagnosis and monitoring of various medical conditions by providing high-resolution visualizations of organs, tissues, and abnormalities.

• How was the regulatory approval process for this device handled by the FDA?

  The Instrumentarium Mega4 received FDA clearance through a 510(k) submission, which demonstrates it was determined to be substantially equivalent to a legally marketed device already on the market. The clearance was granted under the Radiology advisory committee (RA) and assigned product code LNH, with the decision made on February 27, 1992.

• Is the Instrumentarium Mega4 intended for single-use or repeated use in a clinical environment?

  The provided data does not specify reuse or single-use details for the Instrumentarium Mega4. However, as an MRI system, it is typically designed for repeated clinical use in radiology departments, with maintenance and calibration protocols to ensure consistent performance over time.

• What types of models or configurations are available for the Instrumentarium Mega4?

  The data includes multiple FEI numbers (e.g., 3008156140, 3021593788, etc.), which likely represent different serialized or variant models of the Instrumentarium Mega4 system. These identifiers suggest variations may exist in terms of software, hardware upgrades, or technical specifications, but no specific differences are detailed in the provided information.

• How should the Instrumentarium Mega4 be stored to maintain its functionality?

  While the data does not provide explicit storage instructions, MRI systems like the Instrumentarium Mega4 generally require controlled environmental conditions—such as temperature stability, protection from electromagnetic interference, and proper ventilation—to ensure optimal performance and longevity. Manufacturer guidelines (not included here) would specify exact requirements.