Cleared Traditional

K002911 - XSCAN32 TELERADIOLOGY SOFTWARE

K002911 is an FDA 510(k) clearance for XSCAN32 TELERADIOLOGY SOFTWARE, manufactured by Radiographic Digital Imaging, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K002911 · Radiographic Digital Imaging, Inc. · Radiology device
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Jun 2001
Decision
262d
Days
Class 2
Risk

K002911 is an FDA 510(k) clearance for the XSCAN32 TELERADIOLOGY SOFTWARE. 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 Radiographic Digital Imaging, Inc. (Compton, US). The FDA issued a Cleared decision on June 7, 2001 after a review of 262 days - an extended review 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-to-high 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.

FDA 510(k) Submission Details - K002911

510(k) Number K002911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2000
Decision Date June 07, 2001
Days to Decision 262 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 107d · This submission: 262d
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 2293
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K002911.
VORTEX
K012097 · Ultravisual Medical Systems · Jul 2001
TELEPAX
K011173 · Imed Systems & Consulting, LLC · Jul 2001
SYNGO MULTIMODALITY WORKSTATION
K010938 · Siemens Medical Solutions USA, Inc. · Jun 2001
GOODNET
K010763 · Goodman Co., Ltd. · May 2001
AQUARIUS WORKSTATION
K011142 · Terarecon,Inc. · May 2001
MEDIFACE PACS
K010259 · Mediface Co., Ltd. · Apr 2001
K002911 · XSCAN32 TELERADIOLOGY SOFTWARE
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