Rapid DeltaFuse
510(k) K252526
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 | NumberK252526 | Date26 Aug 2025 | StatusActive |
Official records
- FDA 510(k) database K252526
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- Withdrawn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
Overview
AI-generated summary, 24 Sep 2026
The Rapid DeltaFuse is an image processing system intended for radiological applications. It processes and analyzes medical images to assist clinicians in diagnostic decision‑making.
The device was cleared through an FDA 510(k) submission (K252526) and is classified as a Class II system, image processing, radiological device (product code LLZ). It is submitted by Ischemaview, Inc. of Golden, Colorado, and marketed by iSchemaView, Inc.
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