Somatom Smile
by Siemens Medical Solutions USA, Inc.
510(k) K003152
Somatom Smile is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K003152 on 24 Oct 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 | NumberK003152 | Date24 Oct 2000 | StatusActive |
Official records
- FDA 510(k) database K003152
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- Withdrawn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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