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FDA 510(k)

I3SYSTEM-ABD

K-Number: K902007 · 1990-07-20

ApplicantInnovative Imaging, Inc.
Decision Date1990-07-20
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

I3SYSTEM-ABD 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 1990-07-20 under 510(k) number K902007. 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 I3SYSTEM-ABD?

I3SYSTEM-ABD is a medical device that received FDA 510(k) clearance on 1990-07-20. The listed applicant is Innovative Imaging, Inc.. The 510(k) number is K902007.

When did I3SYSTEM-ABD receive FDA 510(k) clearance?

I3SYSTEM-ABD received FDA 510(k) clearance on 1990-07-20, under 510(k) number K902007.

Who is the listed applicant for I3SYSTEM-ABD?

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 I3SYSTEM-ABD?

The FDA product code for I3SYSTEM-ABD is IYO.

Related Clinical Trials

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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.

K041947I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND

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

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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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