Cleared Traditional

K993802 - SHARPVIEW IMAGE ENHANCEMENT SYSTEM

K993802 is an FDA 510(k) clearance for SHARPVIEW IMAGE ENHANCEMENT SYSTEM, manufactured by Context Vision AB. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K993802 · Context Vision AB · Radiology device
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Jan 2000
Decision
70d
Days
Class 2
Risk

K993802 is an FDA 510(k) clearance for the SHARPVIEW IMAGE ENHANCEMENT SYSTEM. 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 Context Vision AB (Findley, US). The FDA issued a Cleared decision on January 18, 2000 after a review of 70 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.

View all Context Vision AB devices

FDA 510(k) Submission Details - K993802

510(k) Number K993802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1999
Decision Date January 18, 2000
Days to Decision 70 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
37d faster than avg
Panel avg: 107d · This submission: 70d
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 1458
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K993802.
BARCOMED 2MP2
K000015 · Barco N.V. · Feb 2000
INTURIS SUITE
K994210 · Philips Medical Systems, Inc. · Feb 2000
PROSOLV ECHOVIEWER, PROSOLV ECHOVIEWER SE, PROSOLV ECHOANALYZER, PROSOLV ECHOSERV, PROSOLV ECHO
K993750 · Problem Solving Concepts, Inc. · Feb 2000
OSCAR NET/CD, MODEL M1.82 600 . O/A/B/C
K993283 · Arnold & Richter Cine Technik · Dec 1999
INTEGRATED DIGITAL MEDICAL RECORD (IDMR)
K993338 · Ibm Israel , Ltd. · Dec 1999
CARDIOVASCULAR MEASUREMENT SYSTEM - VIEW
K993761 · Medis Medical Imaging Systems BV · Dec 1999