Cleared Special

MAXVIEW DIAGNOSTIC WORKSTATION (K984023) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K984023 · Dynamic Healthcare Technologies, Inc. · Radiology device
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Dec 1998
Decision
26d
Days
Class 2
Risk

K984023 is an FDA 510(k) clearance for the MAXVIEW DIAGNOSTIC WORKSTATION. 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 Dynamic Healthcare Technologies, Inc. (Lake Mary, US). The FDA issued a Cleared decision on December 8, 1998 after a review of 26 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 Dynamic Healthcare Technologies, Inc. devices

Submission Details

510(k) Number K984023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1998
Decision Date December 08, 1998
Days to Decision 26 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
81d faster than avg
Panel avg: 107d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 768
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K984023.
POWERVIEW ULTRASOUND WORKSTATION, UIDM-400A
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K992073 · Siemens Medical Solutions USA, Inc. · Sep 1999
ADVANTAGE WINDOWS (AW) FUSION
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ULTRASOUND WORKSTATION, UIWS-300A
K982976 · Toshiba America Medical Systems, In.C · Nov 1998
PLATINUM READING, REVIEW & ANALYSIS WORKSTATION
K981217 · GE Medical Systems · Jun 1998
KODAK DIGITAL SCIENCE ONCOLOGY IMAGE MANAGER
K980118 · Eastman Kodak Company · Mar 1998