Kodak T-Mat H Film SO-118

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K843148 ↗

FDA Product Code

LWZ

Device Class

Class III

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

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See all devices from Eastman Kodak Company →

• What types of medical procedures is the Kodak T-Mat H Film SO-118 intended to support in tissue engineering applications?

  The Kodak T-Mat H Film SO-118 is designed as a scaffold substrate specifically for reconstructive or regenerative procedures where cell attachment and growth are critical. It serves as a foundation to support tissue engineering in controlled clinical settings, such as operating rooms or sterile processing environments, helping guide the development of new tissue structures in medical treatments.

• Is the Kodak T-Mat H Film SO-118 reusable, or is it meant for single-use only?

  The Kodak T-Mat H Film SO-118 is explicitly supplied as a single-use item. This design ensures sterility and consistency for each procedure, aligning with standard sterile medical device protocols to maintain integrity before application in clinical settings.

• How should the Kodak T-Mat H Film SO-118 be stored to maintain its integrity before use?

  Since the Kodak T-Mat H Film SO-118 is a sterile medical device, storage must follow sterile medical device protocols to preserve its integrity. This includes keeping it in a clean, dry environment, protected from contamination, and adhering to manufacturer guidelines to ensure it remains suitable for its intended use in reconstructive or regenerative procedures.

• Can this film be used in MRI scans, or are there any restrictions related to imaging?

  The Kodak T-Mat H Film SO-118 is explicitly not intended for MRI use, as noted in its regulatory documentation. This restriction is likely due to material properties that could interfere with imaging or pose risks during MRI procedures, so clinicians should avoid using it in MRI-compatible applications.

• What regulatory pathway was followed for FDA clearance of the Kodak T-Mat H Film SO-118, and what does that mean for its use?

  The Kodak T-Mat H Film SO-118 received FDA clearance through a Traditional 510(k) pathway (K843148) with a decision classification of *Substantially Equivalent (SESE)*. This means the FDA determined it is as safe and effective as a legally marketed predicate device, allowing it to be marketed for its intended use in tissue engineering applications while adhering to Class III regulatory standards for tissue grafts.