Identifiers
- 510(k) Number
- K874908 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)
The C900 X-Ray Film Processor is an automatic radiographic film processor used in radiology departments for developing X-ray films. It is a Class II medical device that processes radiographic films automatically.
The device is manufactured by Summit Industries, Inc. and is supplied as a single unit. It is not specified as single-use or reusable, and no MRI safety information is provided. The device is authorized under FDA 510(k) clearance with product code IXW and regulation number 892.1900.
Frequently asked questions
What is the C900 X-Ray Film Processor used for?
The C900 X-Ray Film Processor is an automatic radiographic film processor used in radiology departments for developing X-ray films. It is designed to automate the film development process in medical imaging settings.
Is the C900 X-Ray Film Processor single-use or reusable?
The device is not specified as single-use or reusable in the provided information. It is supplied as a single unit, but the manufacturer's instructions regarding reuse would need to be consulted for specific guidance on this matter.
What regulatory approvals does the C900 X-Ray Film Processor have?
The C900 X-Ray Film Processor is authorized under FDA 510(k) clearance with product code IXW and regulation number 892.1900. It is classified as a Class II medical device and was determined to be substantially equivalent to predicate devices.
What are the specifications of the C900 X-Ray Film Processor?
The C900 X-Ray Film Processor is manufactured by Summit Industries, Inc. and is supplied as a single unit. It is an automatic radiographic film processor designed for use in radiology departments. No specific measurements or technical specifications beyond its classification and regulatory information are provided.
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. Sources consulted: C900 X-RAY FILM PROCESSOR (K874908) — FDA 510(k) | Innolitics, Summit C900 X-Ray Film Processor - allmed.wiki, C900 X-RAY FILM PROCESSOR 510 (k) K874908 - FDA.report, Summit Industries | X-Ray Systems & Machines, Equipment Manufacturer, Summit Industries Online Documentation
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K874908 | Class II | Active |
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Manufacturer
- Manufacturer
- Summit Industries, Llc
- FDA Applicant
- Summit Industries, Inc.
Sources (1)
- FDA 510(k) K874908 24 fields · synced Sep 28, 2026