Kodak Ektascan Cp Primary High Freq. Vid.interface

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

510(k) Number

K925721 ↗

FDA Product Code

LMA

Device Class

Class II

Regulation

21 CFR Part 892.2030

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 Ektascan CP Primary High Frequency Video Interface in a clinical setting?

  The Kodak Ektascan CP Primary High Frequency Video Interface is designed to convert analog radiographic images into digital format, enabling precise capture and processing of medical imaging data for diagnostic evaluation in radiology departments.

• Is this device intended for single-use or reusable applications?

  This device is explicitly labeled as a reusable Class II medical device, meaning it is meant to be used multiple times with proper maintenance and cleaning between uses, as outlined in the manufacturer’s guidelines.

• How should the Kodak Ektascan CP be stored to maintain its performance?

  Since the device is non-sterile, it requires proper storage and maintenance per manufacturer instructions to ensure accurate and reliable performance. Storage conditions should protect it from environmental factors that could degrade functionality.

• What regulatory pathway was followed for FDA clearance of this device?

  The Kodak Ektascan CP was cleared through the FDA’s 510(k) process (K925721) under product code LMA, with a traditional review route and a determination of substantial equivalence to a predicate device. It was reviewed by the Radiology (RA) Advisory Committee.

• What types of medical specialties would benefit most from using this device?

  This device is specifically categorized under radiology (OpenFDA medical specialty description) and is intended for use in radiology settings, making it most relevant for diagnostic imaging workflows in hospitals, clinics, or imaging centers.