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FDA 510(k)

SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM

K-Number: K910342 · 1991-08-19

ApplicantMedison Co., Ltd.
Decision Date1991-08-19
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medison Co., Ltd.. It received FDA 510(k) clearance on 1991-08-19 under 510(k) number K910342. 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 SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM?

SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1991-08-19. The listed applicant is Medison Co., Ltd.. The 510(k) number is K910342.

When did SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM receive FDA 510(k) clearance?

SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM received FDA 510(k) clearance on 1991-08-19, under 510(k) number K910342.

Who is the listed applicant for SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM?

The FDA 510(k) record lists Medison Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM?

The FDA product code for SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM is IYO.

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Other records listing Medison Co., Ltd. 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.

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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.

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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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