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)

PDX-2000 PORTABLE DIGITAL X-RAY SYSTEM

K-Number: K012379 · 2001-08-16

ApplicantTrex Enterprises Corp.
Decision Date2001-08-16
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PDX-2000 PORTABLE DIGITAL X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Trex Enterprises Corp.. It received FDA 510(k) clearance on 2001-08-16 under 510(k) number K012379. 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 PDX-2000 PORTABLE DIGITAL X-RAY SYSTEM?

PDX-2000 PORTABLE DIGITAL X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 2001-08-16. The listed applicant is Trex Enterprises Corp.. The 510(k) number is K012379.

When did PDX-2000 PORTABLE DIGITAL X-RAY SYSTEM receive FDA 510(k) clearance?

PDX-2000 PORTABLE DIGITAL X-RAY SYSTEM received FDA 510(k) clearance on 2001-08-16, under 510(k) number K012379.

Who is the listed applicant for PDX-2000 PORTABLE DIGITAL X-RAY SYSTEM?

The FDA 510(k) record lists Trex Enterprises Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PDX-2000 PORTABLE DIGITAL X-RAY SYSTEM?

The FDA product code for PDX-2000 PORTABLE DIGITAL 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

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.

↑