Rapid DeltaFuse
FDA 510(k) K252526 · Ischemaview, Inc.
510(k) numberK252526
Submission
- Device name
- Rapid DeltaFuse
- Applicant
- Ischemaview, Inc.
Golden, CO, US - Received
- August 11, 2025
- Decision date
- August 26, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code LLZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262060 | 3D-RD-SLLZ · Traditional | Radiopharmaceutical Imaging & Dosimetry, LLC | 09/04/2026SE |
| K261500 | KBA3D (v2.4.0)LLZ · Traditional | S.M.A.I.O | 08/17/2026SE |
| K262449 | AdvaViewLLZ · Special | Advahealth Solutions, LLC | 08/14/2026SE |
| K261916 | NeuroQuant PETLLZ · Traditional | Cortechs Labs, Inc. | 08/12/2026SE |
| K260936 | RadioViewAILLZ · Traditional | Neurocareai, Inc. (Dba Savelife.Ai) | 07/31/2026SE |
| 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 |
More from Avara Software
| 510(k) | Device | Decision |
|---|---|---|
| K261085 | Rapid Vessel Occlusion (Rapid VO)QAS · Traditional | 07/13/2026SE |
| K251987 | Rapid Aortic MeasurementsQIH · Traditional | 09/23/2025SE |
| K251533 | Rapid Obstructive Hydrocephalus, Rapid OHQAS · Traditional | 09/04/2025SE |
| K251151 | Rapid CTA 360QAS · Traditional | 07/16/2025SE |
| K243378 | Rapid MLSQIH · Traditional | 05/28/2025SE |
| K243350 | Rapid Neuro3DQIH · Traditional | 01/22/2025SE |
| K233582 | RapidLLZ · Traditional | 04/22/2024SE |
| K232156 | Rapid ASPECTS (v3)POK · Traditional | 01/19/2024SE |
| K233512 | Rapid (6.0)QIH · Special | 01/16/2024SE |
| K232436 | Rapid SDHQAS · Traditional | 10/25/2023SE |
Questions and answers
When was Rapid DeltaFuse cleared by the FDA?
Rapid DeltaFuse (K252526) received a 510(k) decision of Substantially Equivalent on August 26, 2025, 15 days after the submission was received.
What is the product code of K252526?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.