K240353 is an FDA 510(k) clearance for the Hyper Insight - ICH. This device is classified as a Radiological Computer-assisted Triage And Notification Software (Class II - Special Controls, product code QAS).
Submitted by Sk, Inc. (Seongnam-Si, KR). The FDA issued a Cleared decision on July 1, 2024, 147 days after receiving the submission on February 5, 2024.
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 | K240353 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 2024 |
| Decision Date | July 01, 2024 |
| Days to Decision | 147 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 . |