Sentinel, Model Sp-001
510(k) K082582
Sentinel, Model Sp-001 is a Class II device made by C-Rad Positioning Ab, cleared under FDA 510(k) K082582 on 30 Mar 2009, 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 | NumberK082582 | Date30 Mar 2009 | StatusActive |
Official records
- FDA 510(k) database K082582
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IYE
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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