Kodak X-Omatic Radiation Therapy Cass

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

510(k) Number

K843176 ↗

FDA Product Code

IXA

Device Class

Class II

Regulation

21 CFR Part 892.1850

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Eastman Kodak Company →

• What is the primary purpose of the Kodak X-Omatic Radiation Therapy Cass in a clinical setting?

  The Kodak X-Omatic Radiation Therapy Cass is specifically designed to house radiographic film during radiation therapy procedures. Its purpose is to capture high-quality images for treatment planning and verification, ensuring accurate alignment and precise dose delivery to patients. This helps clinicians verify that the radiation is being administered as intended, reducing the risk of errors in therapy.

• Is the Kodak X-Omatic Radiation Therapy Cass intended for single-use or reusable applications?

  The Kodak X-Omatic Radiation Therapy Cass is explicitly described as a reusable component. While it is engineered for durability in radiology settings, it must be handled in accordance with sterile or clean room protocols to maintain its integrity and prevent contamination between uses.

• What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?

  The Kodak X-Omatic Radiation Therapy Cass received FDA clearance through a Traditional 510(k) pathway (K843176) and is classified as a Class II medical device under regulation 21 CFR 892.1850. The clearance was granted by the Radiology (RA) Advisory Committee in 1984, with a decision of 'Substantially Equivalent' (SESE) to a predicate device.

• How should the Kodak X-Omatic Radiation Therapy Cass be stored to ensure optimal performance?

  While the device specifications do not detail storage conditions explicitly, as a reusable radiographic film cassette used in radiation therapy, it should be stored in a clean, dry environment to prevent dust, moisture, or damage. Since it is part of a sterile or clean-room workflow, it should also be kept in a manner that avoids contamination before and after use, adhering to standard radiology department protocols.