Digital Radiography System Radspeed Safire
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K050925 FDA 510(k)
- FDA Product Code
- MQB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1680 FDA 510(k)
- Regulation Number
- 892.1680 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Digital Radiography System Radspeed Safire is a solid state X-ray imager, categorized as a digital flat panel imager. It is designed to capture radiographic images for diagnostic purposes.
This stationary system is regulated as a Class II medical device under FDA 510(k) clearance K050925. It is intended for use in radiology settings.
Frequently asked questions
What is the primary purpose of the Radspeed Safire system?
The Radspeed Safire is a stationary digital radiography system designed to capture radiographic images for diagnostic purposes within radiology settings.
How is this device classified for regulatory purposes?
This device is regulated as a Class II medical device under FDA 510(k) clearance K050925, categorized as a solid state X-ray imager.
Is the Radspeed Safire a portable or stationary system?
The Radspeed Safire is a stationary system, meaning it is designed for fixed installation within a radiology department rather than for mobile or portable use.
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: Radiography - SHIMADZU CORPORATION, Shimadzu Digital Radiography Radspeed Safire - allmed.wiki, Radiography : SHIMADZU CORPORATION, DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE (K050925) — FDA 510 (k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K050925 | Class II | Active |
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Manufacturer
- Manufacturer
- Shimadzu Corp.
Sources (1)
- FDA 510(k) K050925 24 fields · synced Sep 25, 2026