KODAK EKTASIAN HG FILM (EHG-15)

• K Number: K970154
• Device Name: KODAK EKTASIAN HG FILM (EHG-15)
• Manufacturer: EASTMAN KODAK COMPANY
• Date Cleared: 1997-04-04 ( 78 days)
• Product Code: IWZ
• Regulation Number: 892.1840
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 892.1840 Radiographic film.

(a)
Identification. Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides with a photographic emulsion intended to record images during diagnostic radiologic procedures.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9.