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FDA 510(k)

AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM

K-Number: K923273 · 1994-12-27

ApplicantAcoustic Imaging Technologies Corp.
Decision Date1994-12-27
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM 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 1994-12-27 under 510(k) number K923273. 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 AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM?

AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 1994-12-27. The listed applicant is Acoustic Imaging Technologies Corp.. The 510(k) number is K923273.

When did AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM receive FDA 510(k) clearance?

AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM received FDA 510(k) clearance on 1994-12-27, under 510(k) number K923273.

Who is the listed applicant for AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM?

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 AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM?

The FDA product code for AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM 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.

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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.

K924458AI5200 DIAG ULTRA SOUND SYST INCLUD 7.5 & 10.0 MHZK910212COLOR 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 →

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