Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

iQFlex Pro

K-Number: K240009 · 2024-07-03

ApplicantFirst Source, Inc.
Decision Date2024-07-03
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

iQFlex Pro is a medical device manufactured by First Source, Inc.. It received FDA 510(k) clearance on 2024-07-03 under approval number K240009. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iQFlex Pro?

iQFlex Pro is a medical device that received FDA 510(k) clearance on 2024-07-03. It is manufactured by First Source, Inc.. The 510(k) number is K240009.

When was iQFlex Pro approved by the FDA?

iQFlex Pro received FDA 510(k) clearance on 2024-07-03, under approval number K240009.

What company makes iQFlex Pro?

iQFlex Pro is manufactured by First Source, Inc..

What is the FDA product code for iQFlex Pro?

The FDA product code for iQFlex Pro is IZL.

Other Devices by First Source, Inc.

K203703I-Q View K221081iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System

Related Devices (Code: IZL)

K163063UC-5000 Mobile X-RaySource-Ray, Inc. K162990Optima XR240amxGe Medical Systems, LLC K162278Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. K162687Paragon 2Meridian Medical Systems, LLC K161345RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIRSedecal., Sa. K153059HF1202H PowerPlus Portable X-ray EquipmentMinxray, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑