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FDA 510(k)

QSI 9000

K-Number: K894560 · 1990-08-08

ApplicantQuantified Signal Imaging, Inc.
Decision Date1990-08-08
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

QSI 9000 is the device name listed in this FDA 510(k) record. The listed applicant is Quantified Signal Imaging, Inc.. It received FDA 510(k) clearance on 1990-08-08 under 510(k) number K894560. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QSI 9000?

QSI 9000 is a medical device that received FDA 510(k) clearance on 1990-08-08. The listed applicant is Quantified Signal Imaging, Inc.. The 510(k) number is K894560.

When did QSI 9000 receive FDA 510(k) clearance?

QSI 9000 received FDA 510(k) clearance on 1990-08-08, under 510(k) number K894560.

Who is the listed applicant for QSI 9000?

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

What is the FDA product code for QSI 9000?

The FDA product code for QSI 9000 is GWF.

Other records listing Quantified Signal 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.

K904294QSI 9500K863650QUANTIMAP III

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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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