JPI Automatic X-Ray Film Processor
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K950043 FDA 510(k)
- FDA Product Code
- IXW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1900 FDA 510(k)
- Regulation Number
- 892.1900 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
An automatic x-ray film processor is a device used to develop radiographic film through automated chemical processing. It performs the steps such as developing, fixing, washing, and drying to produce diagnostic images.
This device is supplied by JPI Healthcare Co., Ltd. and is intended for use in radiology settings. It operates as a reusable system requiring regular maintenance and chemical replenishment. Authorization is based on FDA 510(k) clearance under product code IXW and regulation number 892.1900.
Frequently asked questions
What is the JPI AUTOMATIC X-RAY FILM PROCESSOR used for?
The JPI AUTOMATIC X-RAY FILM PROCESSOR is used to develop radiographic film through automated chemical processing, performing the steps of developing, fixing, washing, and drying to produce diagnostic images in radiology settings.
How is the JPI AUTOMATIC X-RAY FILM PROCESSOR supplied and maintained?
The device is supplied by JPI Healthcare Co., Ltd. as a reusable system that requires regular maintenance and chemical replenishment to ensure proper operation and consistent image quality.
What regulatory pathway was used for the JPI AUTOMATIC X-RAY FILM PROCESSOR?
The JPI AUTOMATIC X-RAY FILM PROCESSOR received authorization through FDA 510(k) clearance under product code IXW and regulation number 892.1900, based on a determination of substantial equivalence to a predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K950043 | Class II | Active |
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Manufacturer
- Manufacturer
- Jpi Healthcare. Co., Ltd.
- FDA Applicant
- Jpi Healthcare Co, Ltd.
Sources (1)
- FDA 510(k) K950043 24 fields · synced Sep 23, 2026