CustoMED Viewer
by CustoMED Ltd
510(k) K260116
CustoMED Viewer is a Class II device made by CustoMED Ltd, cleared under FDA 510(k) K260116 on 3 Jun 2026, 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 | NumberK260116 | Date3 Jun 2026 | StatusActive |
Official records
- FDA 510(k) database K260116
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- FDA applicant
- CustoMED , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent