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FDA 510(k)

SONARSCAN 128 ULTRASOUND SCANNER

K-Number: K911107 · 1991-06-10

ApplicantDiagnostic Sonar USA
Decision Date1991-06-10
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SONARSCAN 128 ULTRASOUND SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Sonar USA. It received FDA 510(k) clearance on 1991-06-10 under 510(k) number K911107. 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 SONARSCAN 128 ULTRASOUND SCANNER?

SONARSCAN 128 ULTRASOUND SCANNER is a medical device that received FDA 510(k) clearance on 1991-06-10. The listed applicant is Diagnostic Sonar USA. The 510(k) number is K911107.

When did SONARSCAN 128 ULTRASOUND SCANNER receive FDA 510(k) clearance?

SONARSCAN 128 ULTRASOUND SCANNER received FDA 510(k) clearance on 1991-06-10, under 510(k) number K911107.

Who is the listed applicant for SONARSCAN 128 ULTRASOUND SCANNER?

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

What is the FDA product code for SONARSCAN 128 ULTRASOUND SCANNER?

The FDA product code for SONARSCAN 128 ULTRASOUND SCANNER 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 Diagnostic Sonar USA 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.

K827209SYSTEM 287 SCANNER

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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