Cleared Special

K013994 - MODIFICATION TO VIEWSEND MEDICAL

K013994 is an FDA 510(k) clearance for MODIFICATION TO VIEWSEND MEDICAL, manufactured by Klt Telecom, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Special 510(k) pathway after a 59-day FDA review.

K013994 · Klt Telecom, Inc. · Radiology device
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Feb 2002
Decision
59d
Days
Class 2
Risk

K013994 is an FDA 510(k) clearance for the MODIFICATION TO VIEWSEND MEDICAL. 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 Klt Telecom, Inc. (Chantilly, US). The FDA issued a Cleared decision on February 1, 2002 after a review of 59 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.

View all Klt Telecom, Inc. devices

FDA 510(k) Submission Details - K013994

510(k) Number K013994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2001
Decision Date February 01, 2002
Days to Decision 59 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 107d · This submission: 59d
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 Peers - LLZ System, Image Processing, Radiological

All 1465
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K013994.
MFCD 118I
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CORONIS 3MP MEDICL FLAT PANEL DISPLAY SYSTEM
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CAAS II QVA
K012475 · Pie Medical Imaging BV · Oct 2001
KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS
K012155 · Eastman Kodak Company · Aug 2001