Cleared Traditional

K981217 - PLATINUM READING, REVIEW & ANALYSIS WORKSTATION

K981217 is an FDA 510(k) clearance for PLATINUM READING, manufactured by GE Medical Systems. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K981217 · GE Medical Systems · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
76d
Days
Class 2
Risk

K981217 is an FDA 510(k) clearance for the PLATINUM READING, REVIEW & ANALYSIS 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 GE Medical Systems (Waukesha, US). The FDA issued a Cleared decision on June 18, 1998 after a review of 76 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 GE Medical Systems devices

FDA 510(k) Submission Details - K981217

510(k) Number K981217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1998
Decision Date June 18, 1998
Days to Decision 76 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
31d faster than avg
Panel avg: 107d · This submission: 76d
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 2146
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K981217.
DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY)
K982120 · Trex Medical Corp. · Sep 1998
PEDIATRIC INSTATRAK SYSTEM
K981998 · Visualization Technology, Inc. · Aug 1998
PRO VISION
K980648 · Algotec Systems, Ltd. · Jul 1998
THE NETWORK SYSTEM
K980234 · Medical Sni , Ltd. · Jun 1998
IIRAD DIRECTRAY OPERATOR CONSOLE
K980970 · Sterling Diagnostic Imaging, Inc. · Jun 1998
COMPUTED RADIOGRAPHY QUALITY ASSURANCE SOFTWARE
K980168 · Analogic Corp. · Apr 1998