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FDA 510(k)

TOMOPHASE OCTIS

K-Number: K102599 · 2010-12-01

ApplicantTomophase Corporation
Decision Date2010-12-01
Product CodeNQQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TOMOPHASE OCTIS is the device name listed in this FDA 510(k) record. The listed applicant is Tomophase Corporation. It received FDA 510(k) clearance on 2010-12-01 under 510(k) number K102599. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOMOPHASE OCTIS?

TOMOPHASE OCTIS is a medical device that received FDA 510(k) clearance on 2010-12-01. The listed applicant is Tomophase Corporation. The 510(k) number is K102599.

When did TOMOPHASE OCTIS receive FDA 510(k) clearance?

TOMOPHASE OCTIS received FDA 510(k) clearance on 2010-12-01, under 510(k) number K102599.

Who is the listed applicant for TOMOPHASE OCTIS?

The FDA 510(k) record lists Tomophase Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOMOPHASE OCTIS?

The FDA product code for TOMOPHASE OCTIS is NQQ.

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Related Devices (Code: NQQ)

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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