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FDA 510(k)

IMAGO C21 DIAGNOSTIC ULTRASOUND SYSTEM

K-Number: K090059 · 2009-04-30

ApplicantSaset (Chengdu), Inc.
Decision Date2009-04-30
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMAGO C21 DIAGNOSTIC ULTRASOUND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Saset (Chengdu), Inc.. It received FDA 510(k) clearance on 2009-04-30 under 510(k) number K090059. 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 IMAGO C21 DIAGNOSTIC ULTRASOUND SYSTEM?

IMAGO C21 DIAGNOSTIC ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 2009-04-30. The listed applicant is Saset (Chengdu), Inc.. The 510(k) number is K090059.

When did IMAGO C21 DIAGNOSTIC ULTRASOUND SYSTEM receive FDA 510(k) clearance?

IMAGO C21 DIAGNOSTIC ULTRASOUND SYSTEM received FDA 510(k) clearance on 2009-04-30, under 510(k) number K090059.

Who is the listed applicant for IMAGO C21 DIAGNOSTIC ULTRASOUND SYSTEM?

The FDA 510(k) record lists Saset (Chengdu), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMAGO C21 DIAGNOSTIC ULTRASOUND SYSTEM?

The FDA product code for IMAGO C21 DIAGNOSTIC ULTRASOUND SYSTEM is IYO.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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