Cleared Traditional

LVivo Software Application (K200232) - FDA 510(k) Clearance

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

K200232 · Dia Imaging Analysis, Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2020
Decision
145d
Days
Class 2
Risk

K200232 is an FDA 510(k) clearance for the LVivo Software Application. Classified as Automated Radiological Image Processing Software within the QIH classification (a category dominated by AI-based automated radiology processing systems), Class II - Special Controls.

Submitted by Dia Imaging Analysis, Ltd. (Beer-Sheva, IL). The FDA issued a Cleared decision on June 23, 2020 after a review of 145 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 Dia Imaging Analysis, Ltd. devices

Submission Details

510(k) Number K200232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2020
Decision Date June 23, 2020
Days to Decision 145 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
38d slower than avg
Panel avg: 107d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QIH Automated Radiological Image Processing Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Provide Automated Radiological Image Processing And Analysis Tools. Software Implementing Artificial Intelligence Including Nonadaptive Machine Learning Algorithms Trained With Clinical And/or Artificial Data. In These Devices, The Algorithm Training Data Typically Impacts Device Performance. Adaptive Ai Algorithms Are Not Within Scope Of This Product Code.
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

Medicsense USA
George Hattub

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 - QIH Automated Radiological Image Processing Software

All 297
Devices cleared under the same product code (QIH) and FDA review panel - the closest regulatory comparables to K200232.
AI-Rad Companion Prostate MR
K193283 · Siemens Medical Solutions USA, Inc. · Jul 2020
Caption Interpretation Automated Ejection Fraction Software
K200621 · Caption Health · Jul 2020
Ezra Plexo Software
K192969 · Ezra Ai, Inc. · Jul 2020
MEDO ARIA
K200356 · Medo.Ai · Jun 2020
QLAB Advanced Quantification Software
K200974 · Philips Health Care · Jun 2020
uWS-MR
K192601 · Shanghai United Imaging Healthcare Co., Ltd. · Jun 2020