FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Veuron-Brain-mN1
K Number: K203279
·
Decision Jul 12, 2022
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
1098
Applicant Total
5
Review Days
613
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
- Veuron-Brain-mN1
- K Number
- K203279
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Heuron Co., Ltd.
- Date Received
- November 6, 2020
- Decision Date
- July 12, 2022
- Product Code
- LNH
- 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 |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LNH), ordered by most recent decision date.
uMR Astra
FDA 510(k)
FDA Class 2
·Radiology
APERTO Lucent MRI System
FDA 510(k)
FDA Class 2
·Radiology
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
FDA 510(k)
FDA Class 2
·Radiology
S-scan Open (100001800)
FDA 510(k)
FDA Class 2
·Radiology
nordicAudio (1.0)
FDA 510(k)
FDA Class 2
·Radiology
Embrace Neonatal MRI System
FDA 510(k)
FDA Class 2
·Radiology