OPART/Prodiga, OPART/Protenza, OPART/Paragon

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

510(k) Number

K993574 ↗

FDA Product Code

LNH

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Opart, Model Mrt-600

  Class II

  FDA 510(k) K991740 Active Cleared 2 Aug 1999

• Mrt 50A Flexible Body Coil

  Class II

  FDA 510(k) K900285 Active Cleared 9 Mar 1990

• Mrt-50

  Class II

  FDA 510(k) K921413 Active Cleared 14 Aug 1992

• Flexart V3.5 Software

  Class II

  FDA 510(k) K970573 Active Cleared 21 Jul 1997

• Mrt 50A Joint Coil

  Class II

  FDA 510(k) K900727 Active Cleared 9 Mar 1990

• Mrt 50A

  Class II

  FDA 510(k) K903770 Active Cleared 20 Nov 1990

See all devices from Toshiba America Mri, Inc. →

• Are these MRI systems designed for single-use or can they be reused in a clinical setting?

  The OPART/Prodiga, OPART/Protenza, and OPART/Paragon MRI systems are explicitly described as reusable medical equipment for clinical use. Since they are Class II devices intended for repeated imaging procedures, they must follow manufacturer guidelines for maintenance, cleaning, and sterilization to ensure safe and accurate operation.

• What regulatory pathway was followed for FDA clearance of these MRI systems?

  These devices were cleared through the FDA 510(k) process under traditional review, with a clearance number of K993574. They fall under product code LNH and comply with the agency’s special controls for MRI systems, as indicated in the submission details.

• Are there different models or configurations available for these MRI systems?

  The data provided lists multiple FEI numbers (e.g., 3008156140, 3021593788) associated with the OPART/Prodiga, OPART/Protenza, and OPART/Paragon systems, suggesting variations in specific configurations or software versions may exist. However, the core technology remains nuclear magnetic resonance imaging for radiology applications, and no distinct clinical indications are specified beyond general diagnostic imaging.

• How should these MRI systems be stored to maintain their performance and safety?

  While the data does not specify storage conditions in detail, as reusable medical devices, these MRI systems should be stored in a controlled environment—protected from extreme temperatures, humidity, and physical damage—to preserve their structural integrity and calibration. Manufacturer instructions (not provided here) would outline proper storage protocols, including any required maintenance or environmental controls.