FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IQ-UIP
K Number: K242467
·
Decision Dec 19, 2024
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
3
Applicant Total
3
Review Days
121
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Basic Information
- Device Name
- IQ-UIP
- K Number
- K242467
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2085
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Imbio, Inc.
- Date Received
- August 20, 2024
- Decision Date
- December 19, 2024
- 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 |
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