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FDA 510(k)

I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND

K-Number: K041947 · 2004-08-16

ApplicantInnovative Imaging, Inc.
Decision Date2004-08-16
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Imaging, Inc.. It received FDA 510(k) clearance on 2004-08-16 under 510(k) number K041947. 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 I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND?

I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND is a medical device that received FDA 510(k) clearance on 2004-08-16. The listed applicant is Innovative Imaging, Inc.. The 510(k) number is K041947.

When did I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND receive FDA 510(k) clearance?

I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND received FDA 510(k) clearance on 2004-08-16, under 510(k) number K041947.

Who is the listed applicant for I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND?

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

What is the FDA product code for I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND?

The FDA product code for I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND 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 Innovative Imaging, Inc. 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.

K902007I3SYSTEM-ABD

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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