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FDA 510(k)

I-CAT SCANNER

K-Number: K061284 · 2006-07-03

ApplicantImaging Sciences Intl., Inc.
Decision Date2006-07-03
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

I-CAT SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Imaging Sciences Intl., Inc.. It received FDA 510(k) clearance on 2006-07-03 under 510(k) number K061284. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I-CAT SCANNER?

I-CAT SCANNER is a medical device that received FDA 510(k) clearance on 2006-07-03. The listed applicant is Imaging Sciences Intl., Inc.. The 510(k) number is K061284.

When did I-CAT SCANNER receive FDA 510(k) clearance?

I-CAT SCANNER received FDA 510(k) clearance on 2006-07-03, under 510(k) number K061284.

Who is the listed applicant for I-CAT SCANNER?

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

What is the FDA product code for I-CAT SCANNER?

The FDA product code for I-CAT SCANNER is MUH.

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Other records listing Imaging Sciences Intl., 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.

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Related Devices (Code: MUH)

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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