510(k) K242467
- Device
- IQ-UIP
- Applicant
- Imbio, Inc.
- 510(k) number
- K242467
- Product code
- QWO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-12-19
- Date received
- 2024-08-20
- Regulation
- 892.2085
- Classification name
- Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- William McLain
- Address
- 1015 Glenwood Ave. Floor 4 Minneapolis MN US 55405 55405
FDA Registration Numbers
- 3033729853
- 3017426576