Quicktome Software Suite
K-Number: K222359 · 2023-05-30
Decision Date2023-05-30
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Quicktome Software Suite is a medical device manufactured by Omniscient Neurotechnology Pty Ltd (O8t). It received FDA 510(k) clearance on 2023-05-30 under approval 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. It is manufactured by Omniscient Neurotechnology Pty Ltd (O8t). The 510(k) number is K222359.
When was Quicktome Software Suite approved by the FDA?
Quicktome Software Suite received FDA 510(k) clearance on 2023-05-30, under approval number K222359.
What company makes Quicktome Software Suite?
Quicktome Software Suite is manufactured by Omniscient Neurotechnology Pty Ltd (O8t).
What is the FDA product code for Quicktome Software Suite?
The FDA product code for Quicktome Software Suite is LLZ.
Related Clinical Trials
Other Devices by Omniscient Neurotechnology Pty Ltd (O8t)
Related Devices (Code: LLZ)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.