Cleared Traditional

K983392 - DATA RAY CORPORATION DR11021 MEDICAL IMAGING MONITOR

K983392 is an FDA 510(k) clearance for DATA RAY CORPORATION DR11021 MEDICAL IM..., manufactured by Data Ray. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K983392 · Data Ray · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
81d
Days
Class 2
Risk

K983392 is an FDA 510(k) clearance for the DATA RAY CORPORATION DR11021 MEDICAL IMAGING MONITOR. 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 Data Ray (Westminster, US). The FDA issued a Cleared decision on December 15, 1998 after a review of 81 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 Data Ray devices

FDA 510(k) Submission Details - K983392

510(k) Number K983392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1998
Decision Date December 15, 1998
Days to Decision 81 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
26d faster than avg
Panel avg: 107d · This submission: 81d
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 1329
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K983392.
INSTATRAK 3000
K983529 · Visualization Technology, Inc. · Dec 1998
INSIGHT DIAGNOSTIC IMAGING WORKSTATION
K982535 · Neo Imagery Technologies, Inc. · Dec 1998
ADVANTAGE WINDOWS (AW) FUSION
K983256 · GE Medical Systems · Dec 1998
FRAMEWAVE WEB
K983401 · Ml Strategies, Inc. · Dec 1998
PHILIPS INTURIS CARDIO IMAGE VIEWING PACKAGE
K983821 · Philips Medical Systems North America, Inc. · Dec 1998
ULTRASOUND WORKSTATION, UIWS-300A
K982976 · Toshiba America Medical Systems, In.C · Nov 1998