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)

VEX-S 100W INTRAORAL X-RAY SYSTEM

K-Number: K123493 · 2012-12-13

ApplicantVATECH Co., Ltd.
Decision Date2012-12-13
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VEX-S 100W INTRAORAL X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is VATECH Co., Ltd.. It received FDA 510(k) clearance on 2012-12-13 under 510(k) number K123493. 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 VEX-S 100W INTRAORAL X-RAY SYSTEM?

VEX-S 100W INTRAORAL X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 2012-12-13. The listed applicant is VATECH Co., Ltd.. The 510(k) number is K123493.

When did VEX-S 100W INTRAORAL X-RAY SYSTEM receive FDA 510(k) clearance?

VEX-S 100W INTRAORAL X-RAY SYSTEM received FDA 510(k) clearance on 2012-12-13, under 510(k) number K123493.

Who is the listed applicant for VEX-S 100W INTRAORAL X-RAY SYSTEM?

The FDA 510(k) record lists VATECH Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VEX-S 100W INTRAORAL X-RAY SYSTEM?

The FDA product code for VEX-S 100W INTRAORAL X-RAY SYSTEM 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 VATECH Co., Ltd. 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.

K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)K243088Green X 12 SE (PHT-40CHS)K243081Green X 21 (PHT-90CHO)K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)K231796Grreen X 12 (Model: PHT-75CHS)K223058EzRay Air 2 Wall (Model: VEX-S350W)

View all 38 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.

↑