Quantib Brain 1.2
by Quantib B.V.
510(k) K163013
Quantib Brain 1.2 is a Class II device made by Quantib B.V., cleared under FDA 510(k) K163013 on 6 Jan 2017, 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 | NumberK163013 | Date6 Jan 2017 | StatusActive |
Official records
- FDA 510(k) database K163013
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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