Cleared Traditional

K933098 - MEDICAL IMAGE MANAGEMENT SYSTEM/X-RAY TERMINAL (FDA 510(k) Clearance)

Class I Radiology device.

K933098 · Siemens Medical Solutions Health Services Corporat · Radiology device
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Sep 1993
Decision
88d
Days
Class 1
Risk

K933098 is an FDA 510(k) clearance for the MEDICAL IMAGE MANAGEMENT SYSTEM/X-RAY TERMINAL. Classified as System, Digital Image Communications, Radiological (product code LMD), Class I - General Controls.

Submitted by Siemens Medical Solutions Health Services Corporat (Mavern, US). The FDA issued a Cleared decision on September 20, 1993 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2020 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Siemens Medical Solutions Health Services Corporat devices

Submission Details

510(k) Number K933098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1993
Decision Date September 20, 1993
Days to Decision 88 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 107d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LMD System, Digital Image Communications, Radiological
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.2020
Definition A Medical Image Communications Device Provides Electronic Transfer Of Medical Image Data Between Medical Devices. It May Include A Physical Communications Medium, Modems, Interfaces, And A Communications Protocol. It May Provide Simple Image Review Software Functionality For Medical Image Processing And Manipulation, Such As Grayscale Window And Level, Zoom And Pan, User Delineated Geometric Measurements, Compression, Or User Added Image Annotations. The Device Does Not Perform Advanced Image Processing Or Complex Quantitative Functions.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.