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FDA 510(k)

INSIGHT DIAGNOSTIC IMAGING WORKSTATION NIT-DU0-ZOO

K-Number: K965179 · 1997-07-03

ApplicantNeo Imagery Technologies, Inc.
Decision Date1997-07-03
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INSIGHT DIAGNOSTIC IMAGING WORKSTATION NIT-DU0-ZOO is the device name listed in this FDA 510(k) record. The listed applicant is Neo Imagery Technologies, Inc.. It received FDA 510(k) clearance on 1997-07-03 under 510(k) number K965179. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSIGHT DIAGNOSTIC IMAGING WORKSTATION NIT-DU0-ZOO?

INSIGHT DIAGNOSTIC IMAGING WORKSTATION NIT-DU0-ZOO is a medical device that received FDA 510(k) clearance on 1997-07-03. The listed applicant is Neo Imagery Technologies, Inc.. The 510(k) number is K965179.

When did INSIGHT DIAGNOSTIC IMAGING WORKSTATION NIT-DU0-ZOO receive FDA 510(k) clearance?

INSIGHT DIAGNOSTIC IMAGING WORKSTATION NIT-DU0-ZOO received FDA 510(k) clearance on 1997-07-03, under 510(k) number K965179.

Who is the listed applicant for INSIGHT DIAGNOSTIC IMAGING WORKSTATION NIT-DU0-ZOO?

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

What is the FDA product code for INSIGHT DIAGNOSTIC IMAGING WORKSTATION NIT-DU0-ZOO?

The FDA product code for INSIGHT DIAGNOSTIC IMAGING WORKSTATION NIT-DU0-ZOO is LLZ.

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 Neo Imagery Technologies, 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.

K982535INSIGHT DIAGNOSTIC IMAGING WORKSTATION

Related Devices (Code: LLZ)

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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