Quicktome Software Suite— 510(k) K222359

Substantially Equivalent

Omniscient Neurotechnology Pty Ltd (O8t)

FDA 510(k) clearance K222359 for Quicktome Software Suite, Substantially Equivalent on 2023-05-30. Applicant: Omniscient Neurotechnology Pty Ltd (O8t).

Clearance details

Applicant: Omniscient Neurotechnology Pty Ltd (O8t)
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2022-08-04
Decision date: 2023-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sydney, AU

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.