FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ScreenDx
K Number: K241891
·
Decision Jan 10, 2025
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
3
Applicant Total
3
Review Days
196
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ScreenDx
- K Number
- K241891
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2085
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Imvaria, Inc.
- Date Received
- June 28, 2024
- Decision Date
- January 10, 2025
- Product Code
- QWO
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QWO | Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease. | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QWO), ordered by most recent decision date.
Fibresolve (with PCCP)
FDA 510(k)
FDA Class 2
·Radiology
IQ-UIP
FDA 510(k)
FDA Class 2
·Radiology
Fibresolve
FDA 510(k)
FDA Class 2
·Radiology