Cleared Traditional

K080351 - DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI

K080351 is an FDA 510(k) clearance for DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, manufactured by Dexela, Ltd.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K080351 · Dexela, Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
71d
Days
Class 2
Risk

K080351 is an FDA 510(k) clearance for the DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI. 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 Dexela, Ltd. (Waltham, US). The FDA issued a Cleared decision on April 22, 2008 after a review of 71 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.

FDA 510(k) Submission Details - K080351

510(k) Number K080351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2008
Decision Date April 22, 2008
Days to Decision 71 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
36d faster than avg
Panel avg: 107d · This submission: 71d
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 2269
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K080351.
LUMIMED SERIES 5MP DIGITAL FLAT PANEL DISPLAY SYSTEM, MODEL MM50/MM50A
K073358 · Heeyoung Co., Ltd. · Apr 2008
SYNGO DYNAMICS VERSION 7.0
K081018 · Siemens Medical Solutions · Apr 2008
SYNGO MULTIMODALITY WORKPLACE
K072728 · Siemens AG Medical Solutions · Apr 2008
NM APPLICATION SUITE
K080961 · Philips Nuclear Medicine, Inc. · Apr 2008
DIGITAL LIGHTBOX
K080608 · Brainlab AG · Apr 2008
SURGICASE
K073449 · Materialise NV · Apr 2008
K080351 · DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI
Download PDF FDA Summary Dexela, Ltd.