HyperBand
510(k) K162403
HyperBand is a Class II device made by GE Medical Systems, LLC, cleared under FDA 510(k) K162403 on 18 Nov 2016, 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 | NumberK162403 | Date18 Nov 2016 | StatusActive |
Official records
- FDA 510(k) database K162403
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- Withdrawn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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