Cleared Traditional

SIS Software version 3.3.0 (K183019) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence.

K183019 · Surgical Information Sciences, Inc. · Radiology device
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Mar 2019
Decision
139d
Days
Class 2
Risk

K183019 is an FDA 510(k) clearance for the SIS Software version 3.3.0. 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 Surgical Information Sciences, Inc. (Minneapolis, US). The FDA issued a Cleared decision on March 19, 2019 after a review of 139 days - within the typical 510(k) review window.

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 Surgical Information Sciences, Inc. devices

Submission Details

510(k) Number K183019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2018
Decision Date March 19, 2019
Days to Decision 139 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
32d slower than avg
Panel avg: 107d · This submission: 139d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Radiology devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
Janice M. Hogan

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.

Clinical Evidence

ClinicalTrials.gov
NCT02902328 Completed Observational Industry-sponsored

Accuracy Evaluation for SIS Software-based Visualization of Anatomical Brain Structures

Accuracy Evaluation for Software-based Visualization of Anatomical Brain Structures Using Surgical Information Sciences Inc. Algorithms

30
Patients (actual)
Condition studied Software Evaluation for Visualizing Anatomical Structures That Are Not Typically Identified on Clinical MR Images
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Sponsor Surgical Information Sciences Inc. (industry)
Started 2016-03-01 → Primary completion 2016-09-01
Primary outcome
Validation of the accurate visualization of brain structures based on SIS algorithms
Study completed - no results published. This trial concluded in 2016 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

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 K183019.
Mimics Medical
K183105 · Materialise NV · Mar 2019
Synapse PACS
K190232 · Fujifilm Corporation · Mar 2019
uWS-MR
K183164 · Shanghai United Imaging Healthcare Co., Ltd. · Mar 2019
MIM on Linux
K190379 · Mim Software, Inc. · Mar 2019
RADMAX Digital Imaging Software
K182537 · DRGEM Corporation · Mar 2019
Visualase Thermal Therapy System
K181859 · Medtronic Navigation, Inc. · Mar 2019