FDA 510(k)

QSI 9500

K-Number: K904294 · 1991-07-30

ApplicantQuantified Signal Imaging, Inc.

Decision Date1991-07-30

Product CodeOLU

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

QSI 9500 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 1991-07-30 under 510(k) number K904294. The device is classified under product code OLU. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QSI 9500?

QSI 9500 is a medical device that received FDA 510(k) clearance on 1991-07-30. The listed applicant is Quantified Signal Imaging, Inc.. The 510(k) number is K904294.

When did QSI 9500 receive FDA 510(k) clearance?

QSI 9500 received FDA 510(k) clearance on 1991-07-30, under 510(k) number K904294.

Who is the listed applicant for QSI 9500?

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 9500?

The FDA product code for QSI 9500 is OLU.

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.

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Official Source

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