Fuji Computed Radiography Od-F623 Optical-Disk

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

510(k) Number

K921112 ↗

FDA Product Code

KPR

Device Class

Class II

Regulation

21 CFR Part 892.1680

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Fujifilm Medical System U.S.A., Inc. →

• What is the primary purpose of the FUJI Computed Radiography OD-F623 Optical Disk in a clinical setting?

  The FUJI Computed Radiography OD-F623 Optical Disk serves as a reusable optical storage medium for capturing and archiving radiographic images produced by computed radiography systems. It enables efficient data retrieval and processing, allowing radiology departments to store and later access digital X-ray images without the need for physical film. This makes it essential for workflows where digital imaging is integrated into patient care.

• Is the FUJI Computed Radiography OD-F623 Optical Disk single-use or reusable, and what does this mean for maintenance?

  The FUJI Computed Radiography OD-F623 Optical Disk is explicitly designed as a reusable component, meaning it can be used repeatedly within a radiology setting. Since it does not require sterilization, maintenance primarily involves following the manufacturer’s guidelines for handling, cleaning, and storage to ensure optimal performance and longevity. Proper care extends its operational life, reducing replacement costs.

• How should the FUJI Computed Radiography OD-F623 Optical Disk be stored, and are there any environmental considerations?

  The device is intended for use in standard X-ray imaging environments, but specific storage guidelines are implied by its reusable nature and lack of sterilization requirement. While the data does not detail exact storage conditions, it is critical to protect the optical disk from physical damage, moisture, and extreme temperatures. Storing it in a clean, dry environment—preferably in its original packaging or a dedicated case—will help preserve its integrity for repeated use.

• What regulatory pathway was followed for FDA clearance of the FUJI Computed Radiography OD-F623 Optical Disk?

  The FUJI Computed Radiography OD-F623 Optical Disk was cleared through the FDA 510(k) pathway, specifically under a Traditional Review process. It was determined to be substantially equivalent to a legally marketed predicate device, as indicated by the decision code *SESE*. The clearance falls under 21 CFR 892.1680, and the device is classified as a Class II medical device, reflecting its role in radiology imaging systems.

• Can the FUJI Computed Radiography OD-F623 Optical Disk be used in an MRI environment, and why?

  No, the FUJI Computed Radiography OD-F623 Optical Disk is not MRI-safe. The manufacturer explicitly states this in the device description, meaning it should not be used or stored in proximity to MRI machines. The presence of optical or electronic components could pose risks in an MRI environment due to electromagnetic interference or potential damage from the magnetic fields.