Modification to: Lightspeed Plus Mobile CT System
510(k) K012836
Modification to: Lightspeed Plus Mobile CT System is a medical device (FDA Class II; FDA product code JAK, System, X-Ray, Tomography, Computed) made by GE Medical Systems, cleared under FDA 510(k) K012836 on 7 Sep 2001, 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 | NumberK012836 | Date7 Sep 2001 | StatusActive |
Official records
- FDA 510(k) database K012836
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JAK
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1750
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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