DRYSTAR Model 4500M
FDA 510(k)Class II (US FDA 510(k))
by Agfa Corp.
Identifiers
- 510(k) Number
- K012941 FDA 510(k)
- FDA Product Code
- LMC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2040 FDA 510(k)
- Regulation Number
- 892.2040 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The DRYSTAR Model 4500M is a Camera, Multi Format, Radiological, designed for processing and printing radiographic images. It functions as a dry digital printer, converting digital radiographic data into printed output without the use of wet chemical processing. This device supports multiple image formats commonly used in radiology, ensuring compatibility with standard radiographic workflows.
The DRYSTAR Model 4500M is intended for use in radiology departments, where it is supplied as a reusable medical device. It operates within standard radiology environments and adheres to FDA-cleared specifications under the 510(k) pathway, classified under product code LMC as a Class II device. The device is not described as sterile or single-use, and no MRI safety information is provided. Storage and handling follow standard radiology equipment protocols, with no additional regulatory restrictions stated beyond its FDA clearance.
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: K012941 FDA 510 (k) - DRYSTAR | Agfa Corp., DRYSTAR, MODEL 4500M (K012941) — FDA 510(k) | Innolitics, AGFA DRYSTAR 4500 USER MANUAL Pdf Download | ManualsLib, AGFA Drystar 4500M Reference Manual - ManualMachine.com, AGFA DRYSTAR 4500 REFERENCE MANUAL Pdf Download
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K012941 | Class II | Active |
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Manufacturer
- Manufacturer
- Agfa Corp.
Sources (1)
- FDA 510(k) K012941 24 fields · synced Sep 20, 2026