FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
uAI Easy Triage ICH
K Number: K242292
·
Decision Sep 24, 2024
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
85
Applicant Total
4
Review Days
53
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
- uAI Easy Triage ICH
- K Number
- K242292
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2080
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shanghai United Imaging Intelligence Co., Ltd.
- Date Received
- August 2, 2024
- Decision Date
- September 24, 2024
- Product Code
- QAS
- 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 |
|---|---|---|---|
| QAS | Radiological Computer-Assisted Triage And Notification Software | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QAS), ordered by most recent decision date.
Vascular Assist Occlusion Triage (VAOT) (v1.0)
FDA 510(k)
FDA Class 2
·Radiology
BriefCase-Triage
FDA 510(k)
FDA Class 2
·Radiology
EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)
FDA 510(k)
FDA Class 2
·Radiology
JLK-NCCT
FDA 510(k)
FDA Class 2
·Radiology
Annalise Enterprise
FDA 510(k)
FDA Class 2
·Radiology
BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device
FDA 510(k)
FDA Class 2
·Radiology