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, MODEL: BPD60

K-Number: K091255 · 2010-05-12

ApplicantMinxray, Inc.
Decision Date2010-05-12
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MINXRAY, MODEL: BPD60 is the device name listed in this FDA 510(k) record. The listed applicant is Minxray, Inc.. It received FDA 510(k) clearance on 2010-05-12 under 510(k) number K091255. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINXRAY, MODEL: BPD60?

MINXRAY, MODEL: BPD60 is a medical device that received FDA 510(k) clearance on 2010-05-12. The listed applicant is Minxray, Inc.. The 510(k) number is K091255.

When did MINXRAY, MODEL: BPD60 receive FDA 510(k) clearance?

MINXRAY, MODEL: BPD60 received FDA 510(k) clearance on 2010-05-12, under 510(k) number K091255.

Who is the listed applicant for MINXRAY, MODEL: BPD60?

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: BPD60?

The FDA product code for MINXRAY, MODEL: BPD60 is EHD.

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: EHD)

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.

K260795Hand-held Dental X-ray System (HyperLight-M)Changzhou Sifary Medical Technology Co., Ltd.K260367Portable Dental X-ray System Model PDX novaPDX Co., Ltd.K253864NOMAD Pro 3Dental Imaging Technologies CorporationK252110Dental X-RAY Unit (AJX200)Guangzhou Ajax Medical Equipment Co., Ltd.K254018Portable Dental X-ray Device (GT-1)Guilin Refine Medical Instrument Co., Ltd.K252909Diagnostic X-Ray Equipment Model POCT22Ningbo Runyes Medical Instrument 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.

↑