Cleared Traditional

K151774 - CARESTREAM Vue Motion

K151774 is an FDA 510(k) clearance for CARESTREAM Vue Motion, manufactured by Carestream Health, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K151774 · Carestream Health, Inc. · Radiology device
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Sep 2015
Decision
82d
Days
Class 2
Risk

K151774 is an FDA 510(k) clearance for the CARESTREAM Vue Motion. 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 Carestream Health, Inc. (Rochester, US). The FDA issued a Cleared decision on September 21, 2015 after a review of 82 days - a notably fast clearance 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 Carestream Health, Inc. devices

FDA 510(k) Submission Details - K151774

510(k) Number K151774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2015
Decision Date September 21, 2015
Days to Decision 82 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
25d faster than avg
Panel avg: 107d · This submission: 82d
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 1877
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K151774.
Visible Patient Suite
K151988 · Visible Patient, Sas · Oct 2015
DEXIS Webview
K151941 · Imaging Sciences International /Gendex/Dexis · Oct 2015
OrthoVis Web Portal
K151501 · Custom Orthopaedic Solutions, Inc. · Oct 2015
FACT Medical Imaging Sysytem
K143586 · Dexin Medical Imaging Technology Co., Ltd. · Sep 2015
BOX DICOM Viewer
K151957 · Box, Inc. · Sep 2015
HealthMyne PACS
K152186 · Healthmyne, Inc. · Aug 2015