X3C 1590 Digital Radiographic System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K071409 FDA 510(k)
- FDA Product Code
- KPR 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 X3C 1590 Digital Radiographic System is a stationary X-ray system used in radiology. It is a Class II medical device that received FDA 510(k) clearance as substantially equivalent to a predicate device.
The system is manufactured by Imaging Dynamics Company Ltd in Calgary, Alberta, Canada. It is supplied as a stationary system for use in radiology settings and is authorized under FDA 510(k) clearance K071409, granted on June 8, 2007.
Frequently asked questions
What is the X3C 1590 Digital Radiographic System used for?
The X3C 1590 Digital Radiographic System is a stationary X-ray system used in radiology settings to perform diagnostic imaging procedures, as indicated by its classification under the Radiology medical specialty and its intended use as a radiographic system.
How is the X3C 1590 Digital Radiographic System supplied and configured?
The system is supplied as a complete stationary unit designed for fixed installation in radiology departments, manufactured by Imaging Dynamics Company Ltd in Calgary, Alberta, Canada, and includes all components necessary for operation as a digital radiographic system.
What regulatory authorization does the X3C 1590 Digital Radiographic System have?
The X3C 1590 Digital Radiographic System received FDA 510(k) clearance under submission number K071409, which was granted on June 8, 2007, based on a determination of substantial equivalence to a legally marketed predicate device.
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: K071409 FDA 510 (k) - X3C 1590 DIGITAL RADIOGRAPHIC SYSTEM, Dynamics X3C 1590 Digital Radiographic - allmed.wiki, PDF K071409 - X3c 1590 Digital Radiographic System, X3C 1590 DIGITAL RADIOGRAPHIC SYSTEM - Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K071409 | Class II | Active |
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Manufacturer
- Manufacturer
- Imaging Dynamics Company Ltd
- FDA Applicant
- Imaging Dynamics Company , Ltd.
Sources (1)
- FDA 510(k) K071409 24 fields · synced Sep 24, 2026