iQFlex Pro
510(k) K240009
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK240009 | Date3 Jul 2024 | StatusActive |
Official records
- FDA 510(k) database K240009
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IZL
- FDA applicant
- First Source, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1720
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
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.
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Other devices filed under FDA product code IZL (System, X-Ray, Mobile).
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- PHOENIX by Sedecal., Sa.
- SR-130 by Source-Ray, Inc.