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)

COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D

K-Number: K090171 · 2009-04-30

ApplicantE-Woo Technology
Decision Date2009-04-30
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D is the device name listed in this FDA 510(k) record. The listed applicant is E-Woo Technology. It received FDA 510(k) clearance on 2009-04-30 under 510(k) number K090171. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D?

COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D is a medical device that received FDA 510(k) clearance on 2009-04-30. The listed applicant is E-Woo Technology. The 510(k) number is K090171.

When did COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D receive FDA 510(k) clearance?

COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D received FDA 510(k) clearance on 2009-04-30, under 510(k) number K090171.

Who is the listed applicant for COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D?

The FDA 510(k) record lists E-Woo Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D?

The FDA product code for COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D is OAS.

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 E-Woo Technology 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.

K091090DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL XMARU 1717K090526MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSORK090991COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUOK082410MASTER3DSK081847PICASSO MASTER, ECT AND MASTER 3DK070658DENTAL DIGITAL PANORAMIC/3D IMAGING SYSTEM

View all 7 devices →

Related Devices (Code: OAS)

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.

K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.K250839Dental X-ray SystemChangzhou Boen Zhongding Medical Technology Co., Ltd.K260662Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.K253935medXion NEXUSmedXion Technologies, Inc.K260462RCT800Ray Co., Ltd.K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)VATECH 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.

↑