Cleared Traditional

K252526 - Rapid DeltaFuse

K252526 is the FDA 510(k) clearance for Rapid DeltaFuse by Ischemaview, Inc.. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K252526 · Ischemaview, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
15d
Days
Class 2
Risk

K252526 is an FDA 510(k) clearance for the Rapid DeltaFuse. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Ischemaview, Inc. (Golden, US). The FDA issued a Cleared decision on August 26, 2025 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Ischemaview, Inc. devices

Submission Details

510(k) Number K252526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2025
Decision Date August 26, 2025
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 1056
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K252526.
AI-Rad Companion Prostate MR
K252608 · Siemens Healthcare GmbH · Sep 2025
Image Suite
K251168 · Carestream Health, Inc. · Sep 2025
SurgiTwin
K250290 · Twinsight · Aug 2025
Neurovascular Insight V1.0
K243680 · Olea Medical S.A.S. · Aug 2025
RW-1
K232456 · Mediott, Inc. · Aug 2025
Navigo Workstation 2.3 (FPRMC00039)
K250664 · UC-CARE , Ltd. · Aug 2025