DEN220040 is an FDA 510(k) submission for the Fibresolve. 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. (Berkley, US). The FDA issued a Not Cleared (DENG) decision on January 12, 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 | DEN220040 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | June 29, 2022 |
| Decision Date | January 12, 2024 |
| Days to Decision | 562 days |
| Submission Type | Direct |
| Review Panel | Radiology (RA) |
| Summary | - |
| 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. |