Cleared Special

K151957 - BOX DICOM Viewer

K151957 is an FDA 510(k) clearance for BOX DICOM Viewer, manufactured by Box, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Special 510(k) pathway after a 47-day FDA review.

K151957 · Box, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
47d
Days
Class 2
Risk

K151957 is an FDA 510(k) clearance for the BOX DICOM Viewer. 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 Box, Inc. (Los Altos, US). The FDA issued a Cleared decision on September 1, 2015 after a review of 47 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Incremental AI imaging tool. Low regulatory complexity profile. 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 - K151957

510(k) Number K151957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2015
Decision Date September 01, 2015
Days to Decision 47 days
Submission Type Special
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
60d faster than avg
Panel avg: 107d · This submission: 47d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

O Tech, Inc.
CARL ALLETTO

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.

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