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FDA 510(k)

REMEX Xcam6

K-Number: K250597 · 2025-07-31

ApplicantRemedi, Inc.
Decision Date2025-07-31
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

REMEX Xcam6 is the device name listed in this FDA 510(k) record. The listed applicant is Remedi, Inc.. It received FDA 510(k) clearance on 2025-07-31 under 510(k) number K250597. 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 REMEX Xcam6?

REMEX Xcam6 is a medical device that received FDA 510(k) clearance on 2025-07-31. The listed applicant is Remedi, Inc.. The 510(k) number is K250597.

When did REMEX Xcam6 receive FDA 510(k) clearance?

REMEX Xcam6 received FDA 510(k) clearance on 2025-07-31, under 510(k) number K250597.

Who is the listed applicant for REMEX Xcam6?

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

What is the FDA product code for REMEX Xcam6?

The FDA product code for REMEX Xcam6 is IZL.

Other records listing Remedi, 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.

K240759REMEX-GR100K212144Remex KA6K200284R-Sensor, R-Sensor

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

View on FDA Database →

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

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