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)

I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND

K-Number: K103608 · 2010-12-27

ApplicantEllex, Inc.
Decision Date2010-12-27
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND is the device name listed in this FDA 510(k) record. The listed applicant is Ellex, Inc.. It received FDA 510(k) clearance on 2010-12-27 under 510(k) number K103608. 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 I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND?

I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND is a medical device that received FDA 510(k) clearance on 2010-12-27. The listed applicant is Ellex, Inc.. The 510(k) number is K103608.

When did I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND receive FDA 510(k) clearance?

I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND received FDA 510(k) clearance on 2010-12-27, under 510(k) number K103608.

Who is the listed applicant for I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND?

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

What is the FDA product code for I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND?

The FDA product code for I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND 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

Other records listing Ellex, Inc. 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.

K083061ELLEX INNOVATIVE IMAGING EYE CUBED V4

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.

↑