GE CT-Pet System
510(k) K010641
GE CT-Pet System is a Class II device made by GE Medical Systems, Inc., cleared under FDA 510(k) K010641 on 30 Mar 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 | NumberK010641 | Date30 Mar 2001 | StatusActive |
Official records
- FDA 510(k) database K010641
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- Withdrawn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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