Kodak T-Mat M Film SO-245

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

510(k) Number

K860754 ↗

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 Kodak T-Mat M Film SO-245 used for?

  The Kodak T-Mat M Film SO-245 is a cassette radiographic film used in radiology settings to capture diagnostic images, as specified in its device description and intended use within medical imaging workflows.

• How is the Kodak T-Mat M Film SO-245 supplied?

  The device is supplied as a radiographic film cassette, meaning it is pre-loaded in a protective cassette for use with radiographic equipment, ensuring ease of handling and protection from light and contamination.

• Is the Kodak T-Mat M Film SO-245 sterile or single-use?

  The device data does not specify sterility or single-use status; however, as a radiographic film cassette, it is typically designed for single-use exposure to prevent cross-contamination and ensure image quality, though reuse may be possible if properly handled and reloaded per facility protocols.

• What regulatory pathway was used for the Kodak T-Mat M Film SO-245?

  The Kodak T-Mat M Film SO-245 received FDA 510(k) clearance under submission number K860754 in 1986, demonstrating substantial equivalence to a predicate device, which is the standard regulatory route for Class II medical devices like this radiographic film.