K241891 is an FDA 510(k) clearance for the ScreenDx. This device is classified as a Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease. (Class II - Special Controls, product code QWO).
Submitted by Imvaria, Inc. (Berkeley, US). The FDA issued a Cleared decision on January 10, 2025, 196 days after receiving the submission on June 28, 2024.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2085. Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease Is A Prescription Image Processing Device That Analyzes Computed Tomography Images To Suggest The Presence Of Disease Or Of An Imaging Finding Suggestive Of Disease. The Output Of This Device Is Intended To Be Used As Adjunctive Information As Part Of A Referral Pathway In The Overall Diagnostic Assessment Process..
| 510(k) Number | K241891 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 2024 |
| Decision Date | January 10, 2025 |
| Days to Decision | 196 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | QWO - Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2085 |
| Definition | Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease Is A Prescription Image Processing Device That Analyzes Computed Tomography Images To Suggest The Presence Of Disease Or Of An Imaging Finding Suggestive Of Disease. The Output Of This Device Is Intended To Be Used As Adjunctive Information As Part Of A Referral Pathway In The Overall Diagnostic Assessment Process. |