Neowise
FDA 510(k) K260716 · Cefla S.C.
510(k) numberK260716
Submission
- Device name
- Neowise
- Applicant
- Cefla S.C.
Imola (Bo), IT - Received
- March 5, 2026
- Decision date
- May 4, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code LLZ
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| K262060 | 3D-RD-SLLZ · Traditional | Radiopharmaceutical Imaging & Dosimetry, LLC | 09/04/2026SE |
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| K260588 | Cleerly LABSLLZ · Traditional | Cleerly, Inc. | 07/29/2026SE |
| K262462 | TheraSphere 360 Y-90 Management PlatformLLZ · Special | Boston Scientific Corporation | 07/24/2026SE |
| K262143 | ImageGrid StreamVueLLZ · Traditional | Candelis, Inc. | 07/23/2026SE |
| K260500 | ResolutionMDLLZ · Traditional | ResolutionMD, Inc. | 07/21/2026SE |
| K262120 | Avara ViewerLLZ · Traditional | Avara Software | 07/10/2026SE |
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Questions and answers
When was Neowise cleared by the FDA?
Neowise (K260716) received a 510(k) decision of Substantially Equivalent on May 4, 2026, 60 days after the submission was received.
What is the product code of K260716?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.