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)

TOMTEC ECHO-VIEW

K-Number: K934139 · 1995-01-25

ApplicantTomtec Tomographic Technologies GmbH
Decision Date1995-01-25
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TOMTEC ECHO-VIEW is the device name listed in this FDA 510(k) record. The listed applicant is Tomtec Tomographic Technologies GmbH. It received FDA 510(k) clearance on 1995-01-25 under 510(k) number K934139. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOMTEC ECHO-VIEW?

TOMTEC ECHO-VIEW is a medical device that received FDA 510(k) clearance on 1995-01-25. The listed applicant is Tomtec Tomographic Technologies GmbH. The 510(k) number is K934139.

When did TOMTEC ECHO-VIEW receive FDA 510(k) clearance?

TOMTEC ECHO-VIEW received FDA 510(k) clearance on 1995-01-25, under 510(k) number K934139.

Who is the listed applicant for TOMTEC ECHO-VIEW?

The FDA 510(k) record lists Tomtec Tomographic Technologies GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOMTEC ECHO-VIEW?

The FDA product code for TOMTEC ECHO-VIEW is IYO.

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: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, 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.

↑