CustoMED Viewer
FDA 510(k) K260116 · CustoMED , Ltd.
510(k) numberK260116
Submission
- Device name
- CustoMED Viewer
- Applicant
- CustoMED , Ltd.
Ramat Gan, IL - Received
- January 14, 2026
- Decision date
- June 3, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was CustoMED Viewer cleared by the FDA?
CustoMED Viewer (K260116) received a 510(k) decision of Substantially Equivalent on June 3, 2026, 140 days after the submission was received.
What is the product code of K260116?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.