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)

AI5200 DIAG ULTRA SOUND SYST INCLUD 7.5 & 10.0 MHZ

K-Number: K924458 · 1993-01-21

ApplicantAcoustic Imaging Technologies Corp.
Decision Date1993-01-21
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AI5200 DIAG ULTRA SOUND SYST INCLUD 7.5 & 10.0 MHZ is the device name listed in this FDA 510(k) record. The listed applicant is Acoustic Imaging Technologies Corp.. It received FDA 510(k) clearance on 1993-01-21 under 510(k) number K924458. 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 AI5200 DIAG ULTRA SOUND SYST INCLUD 7.5 & 10.0 MHZ?

AI5200 DIAG ULTRA SOUND SYST INCLUD 7.5 & 10.0 MHZ is a medical device that received FDA 510(k) clearance on 1993-01-21. The listed applicant is Acoustic Imaging Technologies Corp.. The 510(k) number is K924458.

When did AI5200 DIAG ULTRA SOUND SYST INCLUD 7.5 & 10.0 MHZ receive FDA 510(k) clearance?

AI5200 DIAG ULTRA SOUND SYST INCLUD 7.5 & 10.0 MHZ received FDA 510(k) clearance on 1993-01-21, under 510(k) number K924458.

Who is the listed applicant for AI5200 DIAG ULTRA SOUND SYST INCLUD 7.5 & 10.0 MHZ?

The FDA 510(k) record lists Acoustic Imaging Technologies Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AI5200 DIAG ULTRA SOUND SYST INCLUD 7.5 & 10.0 MHZ?

The FDA product code for AI5200 DIAG ULTRA SOUND SYST INCLUD 7.5 & 10.0 MHZ 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 Acoustic Imaging Technologies Corp. 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.

K923273AI 5200 DIAGNOSTIC ULTRASOUND SYSTEMK910212COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST

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.

↑