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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 2285
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K013994.
VIATRONIX V3D COLON
K020658 · Viatronix, Inc. · Mar 2002
ADVANTAGE WORKSTATION 4.1
K020483 · GE Medical Systems · Feb 2002
DENTALEYE 2 DENTAL IMAGE MANAGEMENT SYSTEM
K012439 · Radco Data AB · Feb 2002
CORONIS 3MP MEDICL FLAT PANEL DISPLAY SYSTEM
K013922 · Barco N.V. · Jan 2002
VOXAR'S CALCIUM SCORING PRODUCT
K020140 · Voxar Limited · Jan 2002
3DFIS, MODEL IES-FL-101
K013841 · 3Dsharp, Inc. · Jan 2002
K013994 · MODIFICATION TO VIEWSEND MEDICAL
Download PDF FDA Summary Klt Telecom, Inc.