Heuron ICH
FDA 510(k) clearance K233247 · decided 2024-05-15
Clearance details
- K-number
- K233247
- Device name
- Heuron ICH
- Applicant
- Heuron Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-28
- Decision date
- 2024-05-15
- Days to decision
- 230 days
- Clearance type
- Traditional
- Product code
- QAS
- Device class
- 2
- Regulation number
- 892.2080
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Seoul, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.