K232431 is an FDA 510(k) clearance for the syngo.CT Brain Hemorrhage. This device is classified as a Radiological Computer-assisted Triage And Notification Software (Class II - Special Controls, product code QAS).
Submitted by Siemens Medical Solutions USA, Inc. (Knoxville, US). The FDA issued a Cleared decision on March 22, 2024, 224 days after receiving the submission on August 11, 2023.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2080. Radiological Computer-assisted Triage And Notification Software Is An Image Processing Device Intended To Aid In Prioritization And Triage Of Time Sensitive Patient Detection And Diagnosis Based On The Analysis Of Medical Images Acquired From Radiological Signal Acquisition Systems. The Device Identifies Or Prioritizes Time Sensitive Imaging For Review By Prespecified Clinical Users Based On Software-based Image Analysis But Does Not Provide Information From The Image Analysis Other Than Triage And Notification ..
| 510(k) Number | K232431 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 2023 |
| Decision Date | March 22, 2024 |
| Days to Decision | 224 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | QAS — Radiological Computer-assisted Triage And Notification Software |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2080 |
| Definition | Radiological Computer-assisted Triage And Notification Software Is An Image Processing Device Intended To Aid In Prioritization And Triage Of Time Sensitive Patient Detection And Diagnosis Based On The Analysis Of Medical Images Acquired From Radiological Signal Acquisition Systems. The Device Identifies Or Prioritizes Time Sensitive Imaging For Review By Prespecified Clinical Users Based On Software-based Image Analysis But Does Not Provide Information From The Image Analysis Other Than Triage And Notification . |