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DeltaView Model 2.1

by Riverain Medical Group, Llc

510(k) K111776

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK111776 Date28 Dec 2011ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LLZ
FDA applicant
Riverain Medical Group,Llc
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

DeltaView Model 2.1 is a software tool designed for radiology applications. It processes current and prior chest X-ray images of the same patient to create a difference image that highlights areas of change.

This device is authorized under FDA 510(k) clearance K111776. It is categorized under the radiology advisory committee for use in radiography.

Other devices from Riverain Medical Group

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the DeltaView Model 2.1 software?

    DeltaView Model 2.1 is a software tool intended for radiology applications. It functions by processing both current and prior chest X-ray images of the same patient to generate a difference image that highlights areas of change.

  • What is the regulatory status of the DeltaView Model 2.1?

    The DeltaView Model 2.1 is authorized under FDA 510(k) clearance K111776, which was granted on December 28, 2011, following a traditional submission process.

  • In what clinical setting is this software intended to be used?

    The device is categorized under the radiology advisory committee for use in radiography applications, specifically identified by product code LLZ.