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FDA 510(k)

ACUSON IMAGE MANAGEMENT SYSTEM

K-Number: K921670 · 1992-06-25

ApplicantAcuson Corp.
Decision Date1992-06-25
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACUSON IMAGE MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Acuson Corp.. It received FDA 510(k) clearance on 1992-06-25 under 510(k) number K921670. 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 ACUSON IMAGE MANAGEMENT SYSTEM?

ACUSON IMAGE MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1992-06-25. The listed applicant is Acuson Corp.. The 510(k) number is K921670.

When did ACUSON IMAGE MANAGEMENT SYSTEM receive FDA 510(k) clearance?

ACUSON IMAGE MANAGEMENT SYSTEM received FDA 510(k) clearance on 1992-06-25, under 510(k) number K921670.

Who is the listed applicant for ACUSON IMAGE MANAGEMENT SYSTEM?

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

What is the FDA product code for ACUSON IMAGE MANAGEMENT SYSTEM?

The FDA product code for ACUSON IMAGE MANAGEMENT SYSTEM is IYO.

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Other records listing Acuson 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.

K023772KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMK022896CSV12 SOFTWARE VIEWERK022567SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEMK021497CYPRESS ULTRASOUND SYSTEMK010950CYPRESS SYSTEMK0028073D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING

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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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