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JPI X-Ray Film Cassette

by Jpi America, Inc.

510(k) K945328

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK945328 Date20 Jan 1995ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IXA
Device Class
Class II
Regulation
21 CFR Part 892.1850
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The JPI X-Ray Film Cassette is a radiographic film cassette designed for use during diagnostic x-ray procedures. It holds a radiographic film in close contact with an x-ray intensifying screen and provides a light-proof enclosure for the direct exposure of the film.

This single-use device is supplied sterile and is intended for use in radiology settings. It is a Class II medical device cleared under FDA 510(k) number K945328, with the applicant listed as Jpi America, Inc. The device is regulated under product code IXA and is not evaluated for use in MRI environments.

Other devices from Jpi America, Inc.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the JPI X-Ray Film Cassette used for?

    The JPI X-Ray Film Cassette is used for diagnostic x-ray procedures, holding radiographic film in close contact with an x-ray intensifying screen.

  • Is the JPI X-Ray Film Cassette supplied sterile?

    Yes, the JPI X-Ray Film Cassette is supplied sterile, making it suitable for use in radiology settings.

  • Can the JPI X-Ray Film Cassette be reused?

    No, the JPI X-Ray Film Cassette is a single-use device, intended for one-time use during diagnostic x-ray procedures.