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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 the device name listed in this FDA 510(k) record. The listed applicant is First Source, Inc.. It received FDA 510(k) clearance on 2024-07-03 under 510(k) 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. The listed applicant is First Source, Inc.. The 510(k) number is K240009.

When did iQFlex Pro receive FDA 510(k) clearance?

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

Who is the listed applicant for iQFlex Pro?

The FDA 510(k) record lists First Source, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iQFlex Pro?

The FDA product code for iQFlex Pro is IZL.

Other records listing First Source, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221081iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray SystemK203703I-Q View

Related Devices (Code: IZL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260236XLITEGEMSS HEALTHCARE CO., LTD.K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM CorporationK253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemCarestream HealthK253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd.K250976Airbile-100Poskom Co., Ltd.

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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