Identifiers
- 510(k) Number
- K240009 FDA 510(k)
- FDA Product Code
- IZL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1720 FDA 510(k)
- Regulation Number
- 892.1720 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The iQFlex Pro is a Class II X-ray system manufactured by First Source. It is a mobile X-ray system designed for use in radiology departments.
The device is supplied as a mobile system and is regulated under FDA 510(k) clearance with product code IZL. It was cleared by the FDA on July 3, 2024, under K-number K240009.
Frequently asked questions
What is the iQFlex Pro used for?
The iQFlex Pro is a mobile X-ray system designed specifically for use in radiology departments. It provides imaging capabilities in a mobile format for flexible use within healthcare facilities.
How is the iQFlex Pro supplied?
The iQFlex Pro is supplied as a complete mobile system, ready for use in radiology departments. It includes all necessary components for mobile X-ray imaging functionality.
What is the regulatory status of the iQFlex Pro?
The iQFlex Pro is regulated under FDA 510(k) clearance with product code IZL. It was cleared by the FDA on July 3, 2024, under K-number K240009, making it substantially equivalent to predicate devices.
Is the iQFlex Pro single-use or reusable?
The iQFlex Pro is designed as a reusable mobile X-ray system. It is intended for repeated use in clinical settings rather than being disposable or single-use equipment.
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: First Source iQFlex Pro - allmed.wiki, K240009 FDA 510(k) - iQFlex Pro | First Source, Inc., First Source, Inc. FDA 510 (k) Products - Latest 2024
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240009 | Class II | Active |
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Manufacturer
- Manufacturer
- First Source Inc.
- FDA Applicant
- First Source, Inc.
Sources (1)
- FDA 510(k) K240009 24 fields · synced Sep 22, 2026