K221552 is an FDA 510(k) clearance for the EFAI ChestSuite XR Pneumothorax Assessment System. This device is classified as a Radiological Computer-assisted Prioritization Software For Lesions (Class II - Special Controls, product code QFM).
Submitted by Ever Fortune.Ai, Co., Ltd. (Taichung City, TW). The FDA issued a Cleared decision on November 8, 2022, 161 days after receiving the submission on May 31, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2080. Radiological Computer-assisted Prioritization Software For Lesions 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 | K221552 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 2022 |
| Decision Date | November 08, 2022 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | QFM - Radiological Computer-assisted Prioritization Software For Lesions |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2080 |
| Definition | Radiological Computer-assisted Prioritization Software For Lesions 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. |