Cleared Traditional

K141475 - ENDOSIZE

K141475 is an FDA 510(k) clearance for ENDOSIZE, manufactured by Therenva Sas. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K141475 · Therenva Sas · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
57d
Days
Class 2
Risk

K141475 is an FDA 510(k) clearance for the ENDOSIZE. 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 Therenva Sas (Rennes, FR). The FDA issued a Cleared decision on July 31, 2014 after a review of 57 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 Therenva Sas devices

FDA 510(k) Submission Details - K141475

510(k) Number K141475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2014
Decision Date July 31, 2014
Days to Decision 57 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 107d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

LLZ Device Classification - Class 2, Special Controls

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

Regulatory Technology Services, LLC
MARK JOB

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 2146
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K141475.
ORTOMED
K131348 · Infomed Servicios Informaticos S.L. · Aug 2014
REMOTEYE VIEWER
K141061 · Neologica S.R.L. · Aug 2014
VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA)
K141302 · Vital Images, Inc. · Aug 2014
SYNGO.MR NEUROLOGY, SYNGO.MMR GENERAL
K140897 · Siemens Medical Solutions USA, Inc. · Jul 2014
ESIE APPS SUITE
K141554 · Siemens Medical Solutions USA, Inc. · Jul 2014
DCAS I
K140869 · Gp&P Co., Ltd. · Jul 2014