3M XP515 X-Ray Film Processor
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K880563 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 3M XP515 X-Ray Film Processor is an automatic radiographic-film processor manufactured by 3M Company. It is designed to process X-ray film for medical imaging applications.
The device is supplied as a single-use or reusable unit, depending on the configuration. It is not MRI-safe and requires proper storage conditions. The 3M XP515 X-Ray Film Processor has received FDA 510(k) clearance (K880563) and is classified as a Class II medical device under Special Controls.
Frequently asked questions
What is the 3M XP515 X-Ray Film Processor used for?
The 3M XP515 X-Ray Film Processor is an automatic radiographic-film processor designed to process X-ray film for medical imaging applications.
Is the 3M XP515 X-Ray Film Processor reusable?
The device is supplied as a single-use or reusable unit, depending on the configuration.
Does the 3M XP515 X-Ray Film Processor require special storage conditions?
Yes, the 3M XP515 X-Ray Film Processor requires proper storage conditions.
Is the 3M XP515 X-Ray Film Processor MRI-safe?
No, the 3M XP515 X-Ray Film Processor is not MRI-safe.
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: 3M XP515 X-Ray Film Processor - allmed.wiki, K880563 FDA 510(k) - 3M XP515 X-RAY FILM PROCESSOR | 3M Company, 3M XP515 X-RAY FILM PROCESSOR (K880563) — FDA 510(k) | Innolitics, FDA Browser - Cleared 510 (K) - 3M XP515 X-RAY FILM PROCESSOR (K880563), K880563 FDA 510(k) - 3M XP515 X-RAY FILM PROCESSOR | 3M Company
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K880563 | Class II | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K880563 24 fields · synced Sep 21, 2026