3M Trimatic M Modular System and Accessories
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K880565 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 Trimatic M Modular System is an Automatic Radiographic-Film Processor (Device Class II) designed for radiology applications. It automates the unloading of exposed x-ray film from cassettes, processing the film, and reloading cassettes with fresh film of matching size and type, ensuring efficient workflow in radiographic imaging.
This system is supplied as a reusable, non-sterile modular unit intended for use in radiology departments. It operates in standard clinical environments and adheres to FDA 510(k) clearance (K880565) under the Radiology advisory committee. The modular design accommodates various film sizes, and its regulatory status is confirmed via the Traditional 510K pathway with a Substantially Equivalent determination.
Frequently asked questions
What types of film sizes does the 3M Trimatic M Modular System support, and how does its modular design benefit radiology workflows?
The 3M Trimatic M Modular System is designed to accommodate various film sizes, though the exact sizes are not specified in the data. Its modular design allows for flexibility in handling different film types and sizes, automating the process of unloading exposed film from cassettes, processing it, and reloading cassettes with fresh film. This streamlines workflow efficiency in radiology departments by reducing manual handling and ensuring consistent film size and type matching.
Is the 3M Trimatic M Modular System reusable or single-use, and what are the sterility considerations for its use?
The 3M Trimatic M Modular System is explicitly described as a reusable, non-sterile modular unit. Since it is intended for use in standard clinical environments (not sterile procedures), it does not require sterile packaging or handling. However, proper cleaning and maintenance protocols should be followed to ensure reliable performance and prevent cross-contamination between uses.
How is the 3M Trimatic M Modular System regulated, and what does its FDA clearance status indicate about its safety and effectiveness?
The system holds FDA 510(k) clearance (K880565) under the Radiology advisory committee, classified as a Device Class II Automatic Radiographic-Film Processor. Its clearance was determined through the Traditional 510(k) pathway with a Substantially Equivalent (SESE) finding, meaning it was deemed comparable to a legally marketed predicate device in terms of safety and effectiveness. This status indicates that the device meets regulatory standards for use in radiographic imaging applications.
What is the primary purpose of the 3M Trimatic M Modular System in a radiology department, and how does it improve efficiency?
The system automates the entire process of handling exposed x-ray film—unloading cassettes, processing the film, and reloading cassettes with fresh film of the correct size and type. This eliminates manual steps, reduces human error, and ensures a consistent workflow, which significantly improves efficiency in radiology departments by saving time and minimizing disruptions during imaging procedures.
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 Trimatic M Modular And Accessories - allmed.wiki, 3M TRIMATIC M MODULAR… — K880565 · DeviceClearance, PDF K880565 - 3m Trimatic M Modular System and Accessories, 3m Trimatic Modular Advanced Processing System and 3m Aps Automatic ..., 3m Trimatic Modular Advanced Processing System and 3m Aps Automatic ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K880565 | Class II | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K880565 24 fields · synced Sep 19, 2026