Cleared Traditional

K111776 - DELTAVIEW MODEL 2.1

K111776 is an FDA 510(k) clearance for DELTAVIEW MODEL 2.1, manufactured by Riverain Medical Group,Llc. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K111776 · Riverain Medical Group,Llc · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
188d
Days
Class 2
Risk

K111776 is an FDA 510(k) clearance for the DELTAVIEW MODEL 2.1. 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 Riverain Medical Group,Llc (Miamisburg, US). The FDA issued a Cleared decision on December 28, 2011 after a review of 188 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 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.

FDA 510(k) Submission Details - K111776

510(k) Number K111776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2011
Decision Date December 28, 2011
Days to Decision 188 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
81d slower than avg
Panel avg: 107d · This submission: 188d
Pathway characteristics
Predicate-based equivalence.

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

Clinical Evidence

ClinicalTrials.gov
NCT01261507 Completed Observational

Reader Study of DeltaView™ Chest Radiograph Software

Reader Study to Demonstrate That Use of DeltaView™ is Superior to the Use Standard Prior and Current Antero/Posterior (AP/PA) X-ray Image Pair

15
Patients (actual)
1
Site
Condition studied Lung Neoplasm
Eligibility All sexes · 35 Years+
Principal investigator Matthew T Freedman, MD, MBA
Sponsor Georgetown University
Started 2010-11-01 → Primary completion 2011-12-01 → Completed 2012-12-01
Primary outcome
Localized Receiver Operating Characteristic (LROC) Comparison
Secondary outcome
Sensitivity and Specificity
View full study on ClinicalTrials.gov

Regulatory Peers - LLZ System, Image Processing, Radiological

All 2285
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K111776 · DELTAVIEW MODEL 2.1
Download PDF FDA Summary Riverain Medical Grou…