Radlink GPS Pro Imaging
510(k) K242161
Radlink GPS Pro Imaging is a Class II device made by Radlink, Inc., cleared under FDA 510(k) K242161 on 18 Mar 2025, 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 | NumberK242161 | Date18 Mar 2025 | StatusActive |
Official records
- FDA 510(k) database K242161
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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