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FDA 510(k)

AI5200 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCER

K-Number: K895071 · 1989-10-12

ApplicantAcoustic Imaging
Decision Date1989-10-12
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AI5200 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCER is the device name listed in this FDA 510(k) record. The listed applicant is Acoustic Imaging. It received FDA 510(k) clearance on 1989-10-12 under 510(k) number K895071. 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 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCER?

AI5200 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCER is a medical device that received FDA 510(k) clearance on 1989-10-12. The listed applicant is Acoustic Imaging. The 510(k) number is K895071.

When did AI5200 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCER receive FDA 510(k) clearance?

AI5200 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCER received FDA 510(k) clearance on 1989-10-12, under 510(k) number K895071.

Who is the listed applicant for AI5200 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCER?

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

What is the FDA product code for AI5200 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCER?

The FDA product code for AI5200 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCER 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 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.

K893833AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM W/DOPPLER

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.

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