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)

X-RAY VISIONS

K-Number: K954172 · 1996-03-15

ApplicantImage Visions, LLC
Decision Date1996-03-15
Product CodeLMD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

X-RAY VISIONS is the device name listed in this FDA 510(k) record. The listed applicant is Image Visions, LLC. It received FDA 510(k) clearance on 1996-03-15 under 510(k) number K954172. The device is classified under product code LMD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-RAY VISIONS?

X-RAY VISIONS is a medical device that received FDA 510(k) clearance on 1996-03-15. The listed applicant is Image Visions, LLC. The 510(k) number is K954172.

When did X-RAY VISIONS receive FDA 510(k) clearance?

X-RAY VISIONS received FDA 510(k) clearance on 1996-03-15, under 510(k) number K954172.

Who is the listed applicant for X-RAY VISIONS?

The FDA 510(k) record lists Image Visions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X-RAY VISIONS?

The FDA product code for X-RAY VISIONS is LMD.

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: LMD)

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.

K994329IIVS INTEGRATED IMAGE VIEWING STATIONTerarecon,Inc.K992698STENTOR, PAGEVIEWStentor, Inc.K992426RAYPAX WEB CLINICAL SYSTEMSamsung Sds Co., Ltd.K992352ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0Inteleradiology, Inc.K991537SAMSUNG RAYPAX SYSTEMSamsung Sds Co., Ltd.K984000STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEMSurgical Navigation Technologies, Inc.

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.

↑