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FDA 510(k)

Quicktome Software Suite

K-Number: K222359 · 2023-05-30

ApplicantOmniscient Neurotechnology Pty Ltd (O8t)
Decision Date2023-05-30
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Quicktome Software Suite is the device name listed in this FDA 510(k) record. The listed applicant is Omniscient Neurotechnology Pty Ltd (O8t). It received FDA 510(k) clearance on 2023-05-30 under 510(k) number K222359. 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 Quicktome Software Suite?

Quicktome Software Suite is a medical device that received FDA 510(k) clearance on 2023-05-30. The listed applicant is Omniscient Neurotechnology Pty Ltd (O8t). The 510(k) number is K222359.

When did Quicktome Software Suite receive FDA 510(k) clearance?

Quicktome Software Suite received FDA 510(k) clearance on 2023-05-30, under 510(k) number K222359.

Who is the listed applicant for Quicktome Software Suite?

The FDA 510(k) record lists Omniscient Neurotechnology Pty Ltd (O8t) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Quicktome Software Suite?

The FDA product code for Quicktome Software Suite is LLZ.

Other records listing Omniscient Neurotechnology Pty Ltd (O8t) 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.

K203518Quicktome

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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