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)

CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris

K-Number: K171353 · 2017-06-07

ApplicantMinxray, Inc.
Decision Date2017-06-07
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris is a medical device manufactured by Minxray, Inc.. It received FDA 510(k) clearance on 2017-06-07 under approval number K171353. 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 CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris?

CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris is a medical device that received FDA 510(k) clearance on 2017-06-07. It is manufactured by Minxray, Inc.. The 510(k) number is K171353.

When was CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris approved by the FDA?

CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris received FDA 510(k) clearance on 2017-06-07, under approval number K171353.

What company makes CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris?

CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris is manufactured by Minxray, Inc..

What is the FDA product code for CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris?

The FDA product code for CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris is IZL.

Related Clinical Trials

NCT06868979 Optical Imaging in X-linked Disorders. RECRUITING NCT04534556 Wireless Nerve Stimulation Device To Enhance Recovery After Stroke ENROLLING_BY_INVITATION NCT06951035 Impact of rTMS on BCI Control in Upper Limb Motor Rehabilitation of Patients With Chronic Stroke RECRUITING NCT07534072 Efficacy of Skeletally Anchored Modified Leaf Expander in Maxillary Molar Distalization COMPLETED NCT07505784 Transcranial Alternating Current Stimulation in Frontotemporal Dementia RECRUITING NCT07491068 The Accuracy and Efficacy of Large Language Model Written Hospital Course Summaries NOT_YET_RECRUITING

Other Devices by Minxray, Inc.

K153059HF1202H PowerPlus Portable X-ray Equipment K182207TR90BH K191451CMDR 2CW (Multiple models) K201575CMDR 2C (Multiple Models) K210479IMPACT and X-Ranger

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.

↑