Spiral Imaging Option
510(k) K000802
Spiral Imaging Option is a Class II device made by GE Medical Systems, cleared under FDA 510(k) K000802 on 26 May 2000, 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 | NumberK000802 | Date26 May 2000 | StatusActive |
Official records
- FDA 510(k) database K000802
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- Withdrawn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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