K203518 is an FDA 510(k) clearance for the Quicktome. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Omniscient Neurotechnology Pty Ltd (O8t) (Sydney, AU). The FDA issued a Cleared decision on March 9, 2021, 98 days after receiving the submission on December 1, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K203518 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 2020 |
| Decision Date | March 09, 2021 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LLZ - System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |