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FDA 510(k)

iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System

K-Number: K221081 · 2022-06-13

ApplicantFirst Source, Inc.
Decision Date2022-06-13
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System is a medical device manufactured by First Source, Inc.. It received FDA 510(k) clearance on 2022-06-13 under approval number K221081. 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 M Mobile X-ray System, iQFlex MD Mobile X-ray System?

iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System is a medical device that received FDA 510(k) clearance on 2022-06-13. It is manufactured by First Source, Inc.. The 510(k) number is K221081.

When was iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System approved by the FDA?

iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System received FDA 510(k) clearance on 2022-06-13, under approval number K221081.

What company makes iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System?

iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System is manufactured by First Source, Inc..

What is the FDA product code for iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System?

The FDA product code for iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System is IZL.

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Other Devices by First Source, Inc.

K203703I-Q View K240009iQFlex Pro

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

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

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