FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Heuron ICH
K Number: K233247
·
Decision May 15, 2024
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
85
Applicant Total
5
Review Days
230
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Basic Information
- Device Name
- Heuron ICH
- K Number
- K233247
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2080
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Heuron Co., Ltd.
- Date Received
- September 28, 2023
- Decision Date
- May 15, 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 |
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