Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MINXRAY P300 X-RAY SYSTEM

K-Number: K911841 · 1991-08-26

ApplicantMinxray, Inc.
Decision Date1991-08-26
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MINXRAY P300 X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Minxray, Inc.. It received FDA 510(k) clearance on 1991-08-26 under 510(k) number K911841. 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 P300 X-RAY SYSTEM?

MINXRAY P300 X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 1991-08-26. The listed applicant is Minxray, Inc.. The 510(k) number is K911841.

When did MINXRAY P300 X-RAY SYSTEM receive FDA 510(k) clearance?

MINXRAY P300 X-RAY SYSTEM received FDA 510(k) clearance on 1991-08-26, under 510(k) number K911841.

Who is the listed applicant for MINXRAY P300 X-RAY SYSTEM?

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 P300 X-RAY SYSTEM?

The FDA product code for MINXRAY P300 X-RAY SYSTEM is IZL.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Minxray, 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.

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

View all 17 devices →

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.

↑