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)
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.

View all Riverain Medical Group,Llc devices

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
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 107d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - LLZ System, Image Processing, Radiological

All 1276
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K111776.
X-RAY VVA
K112807 · Medis Medical Imaging Systems BV · Feb 2012
RADIFORCE RX240
K113844 · Eizo Nanao Corporation · Feb 2012
CAAS A-VALVE
K113076 · Pie Medical Imaging BV · Jan 2012
21.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023)
K113443 · Totoku Electric Co., Ltd. · Dec 2011
SYNAPSE MPR FUSION
K113244 · Fujifilm Medical System U.S.A., Inc. · Dec 2011
21.3INCH (54CM)COLOR LCD MONITOR CCL256I2(CL21256)
K113136 · Totoku Electric Co., Ltd. · Dec 2011