UMI X-RAY FILM CASSETTE

• K Number: K971431
• Device Name: UMI X-RAY FILM CASSETTE
• Manufacturer: UMI INTL.
• Date Cleared: 1997-05-20 ( 33 days)
• Product Code: IXA
• Regulation Number: 892.1850
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

X-Ray Film's Change for X-Ray Machine

Device Description

X-Ray Film Cassette/Radiographic

AI/ML Overview

The provided documents are a 510(k) clearance letter from the FDA and an "Indications for Use Statement" for an "X-Ray Film Cassette/Radiographic" device. These documents do not contain detailed information about the acceptance criteria and the study that proves the device meets those criteria for software or AI-driven medical devices.

The FDA letter (K971431) dates back to May 20, 1997, and is for a physical X-ray film cassette. At that time, AI-powered medical devices as we know them today did not exist, and the regulatory pathway for such devices, including requirements for performance studies, was not established in the same way.

Therefore, I cannot provide the requested information based on the provided text. The document is about a traditional hardware component for X-ray imaging, not a digital or AI-driven diagnostic tool.

Regulation Number and Section

§ 892.1850 Radiographic film cassette.

(a)
Identification. A radiographic film cassette is a device intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film.(b)
Classification. Class II (special 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.