Cleared Traditional

Clarify DL (K241350) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K241350 · Ge Medical Systems Israel, Functional Imaging · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2025
Decision
235d
Days
Class 2
Risk

K241350 is an FDA 510(k) clearance for the Clarify DL. 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 Ge Medical Systems Israel, Functional Imaging (Tirat Hacarmel, IL). The FDA issued a Cleared decision on January 3, 2025 after a review of 235 days - an extended review 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-to-high 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 Ge Medical Systems Israel, Functional Imaging devices

Submission Details

510(k) Number K241350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2024
Decision Date January 03, 2025
Days to Decision 235 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
128d slower than avg
Panel avg: 107d · This submission: 235d
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 Consultant

GE Healthcare
Maysana Mousa Elias

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 787
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K241350.
SpectoMed (v1.0)
K242205 · Specto Medical · Jan 2025
ApolloHipX (THR.SS.0001)
K241808 · Corin U.S.A. Limited · Jan 2025
Brainomix 360 e-CTA
K242123 · Brainomix Limited · Jan 2025
Lightning Viewer
K242362 · Nexsys Electronics Inc. Dba Medweb · Dec 2024
aprevo® Digital Planning
K242599 · Carlsmed, Inc. · Dec 2024
PeekMed web
K240926 · Peek Health, S.A. · Dec 2024