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FDA 510(k)

MINXRAY MODEL CMDR-2S

K-Number: K100449 · 2010-04-23

ApplicantMinxray, Inc.
Decision Date2010-04-23
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MINXRAY MODEL CMDR-2S is the device name listed in this FDA 510(k) record. The listed applicant is Minxray, Inc.. It received FDA 510(k) clearance on 2010-04-23 under 510(k) number K100449. 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 MINXRAY MODEL CMDR-2S?

MINXRAY MODEL CMDR-2S is a medical device that received FDA 510(k) clearance on 2010-04-23. The listed applicant is Minxray, Inc.. The 510(k) number is K100449.

When did MINXRAY MODEL CMDR-2S receive FDA 510(k) clearance?

MINXRAY MODEL CMDR-2S received FDA 510(k) clearance on 2010-04-23, under 510(k) number K100449.

Who is the listed applicant for MINXRAY MODEL CMDR-2S?

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

What is the FDA product code for MINXRAY MODEL CMDR-2S?

The FDA product code for MINXRAY MODEL CMDR-2S is IZL.

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Other records listing Minxray, Inc. as applicant

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K210479IMPACT and X-RangerK201575CMDR 2C (Multiple Models)K191451CMDR 2CW (Multiple models)K182207TR90BHK171353CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisK153059HF1202H PowerPlus Portable X-ray Equipment

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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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