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FDA 510(k)

DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480

K-Number: K911584 · 1991-10-24

ApplicantPie Medical Equipment B.V.
Decision Date1991-10-24
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480 is the device name listed in this FDA 510(k) record. The listed applicant is Pie Medical Equipment B.V.. It received FDA 510(k) clearance on 1991-10-24 under 510(k) number K911584. 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 DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480?

DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480 is a medical device that received FDA 510(k) clearance on 1991-10-24. The listed applicant is Pie Medical Equipment B.V.. The 510(k) number is K911584.

When did DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480 receive FDA 510(k) clearance?

DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480 received FDA 510(k) clearance on 1991-10-24, under 510(k) number K911584.

Who is the listed applicant for DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480?

The FDA 510(k) record lists Pie Medical Equipment B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480?

The FDA product code for DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480 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 Pie Medical Equipment B.V. 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.

K982203CAAS II LVA BIPLANE OPTIONK945540CAAS IIK915647DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC250K912819SC1150 CW/PDK911043HEMISPHERE MULTIPLANE ENDORECTAL PROBEK9110447.5 MHZ APAS TRANSDUCER (ART.NOL: 50.04918.1)

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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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