Brainscan Conformal Rt Module
by Brainlab AG
510(k) K971367
Brainscan Conformal Rt Module is a Class II device made by Brainlab AG, cleared under FDA 510(k) K971367 on 27 Oct 1997, 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 | NumberK971367 | Date27 Oct 1997 | StatusActive |
Official records
- FDA 510(k) database K971367
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IYE
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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