Veuron-Brain-mN1
510(k) K203279
Veuron-Brain-mN1 is a medical device (FDA Class II; FDA product code LNH, System, Nuclear Magnetic Resonance Imaging) made by Heuron Co., Ltd., cleared under FDA 510(k) K203279 on 12 Jul 2022, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK203279 | Date12 Jul 2022 | StatusActive |
Official records
- FDA 510(k) database K203279
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LNH
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1000
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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