X3C 1600 Digital Radiographic System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K071403 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 1600 Digital Radiographic System is a digital radiographic system. It is a modification to the Xplorer 1600 system where the Xplorer 1000 digital radiographic detector is replaced with the X3C digital radiographic detector.
The system is a Class II X-ray system. It is manufactured by Imaging Dynamics Company Ltd. The FDA has issued a 510(k) clearance for this model (2007).
Frequently asked questions
What is the X3C 1600 Digital Radiographic System?
The X3C 1600 Digital Radiographic System is a digital radiographic system. It is a modification to the Xplorer 1600 system where the Xplorer 1000 digital radiographic detector is replaced with the X3C digital radiographic detector.
What is the regulatory status of the X3C 1600 Digital Radiographic System?
The X3C 1600 Digital Radiographic System is a Class II X-ray system. The FDA has issued a 510(k) clearance for this model, which was granted in 2007.
Who manufactures the X3C 1600 Digital Radiographic System?
The X3C 1600 Digital Radiographic System is manufactured by Imaging Dynamics Company Ltd.
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: X3C 1600 Digital Radiographic System - Digital Radiographic System ..., X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM - Innolitics, Dynamics X3C 1600 Digital Radiographic - allmed.wiki, Imaging Dynamics Company Ltd 1600 X3C X3C 1600 Plus Digital ... - RevMed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K071403 | Class II | Active |
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Manufacturer
- Manufacturer
- Imaging Dynamics Company Ltd
- FDA Applicant
- Imaging Dynamics Company , Ltd.
Sources (1)
- FDA 510(k) K071403 24 fields · synced Sep 26, 2026