Cleared Traditional

K955000 - REMOTE VIEWING SYSTEM MEDICAL IMAGE DISPLAY MODULE

K955000 is an FDA 510(k) clearance for REMOTE VIEWING SYSTEM MEDICAL IMAGE DIS..., manufactured by Cerner Corp.. The device is a Class 1 Radiology device with product code LMD cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K955000 · Cerner Corp. · Radiology device
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Jan 1996
Decision
86d
Days
Class 1
Risk

K955000 is an FDA 510(k) clearance for the REMOTE VIEWING SYSTEM MEDICAL IMAGE DISPLAY MODULE. Classified as System, Digital Image Communications, Radiological (product code LMD), Class I - General Controls.

Submitted by Cerner Corp. (Kansas City, US). The FDA issued a Cleared decision on January 26, 1996 after a review of 86 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 Cerner Corp. devices

FDA 510(k) Submission Details - K955000

510(k) Number K955000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1995
Decision Date January 26, 1996
Days to Decision 86 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
21d faster than avg
Panel avg: 107d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

LMD Device Classification - Class 1, General Controls

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.

Regulatory Peers - LMD System, Digital Image Communications, Radiological

All 30
Devices cleared under the same product code (LMD) and FDA review panel - the closest regulatory comparables to K955000.
FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666
K970293 · Fujifilm Medical System U.S.A., Inc. · Mar 1997
KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGER
K960382 · Eastman Kodak Company · Apr 1996
PHILIPS SITE VIEW WORKSTATION
K960809 · Philips Medical Systems North America, Inc. · Apr 1996
SIENET SPI SPOOLER
K953552 · Siemens Medical Solutions USA, Inc. · Oct 1995
MODEM TRANSFER APPLICATION SOFTWARE NSMD-001A & NSMD-070A
K952484 · Toshiba America Medical Systems, In.C · Jun 1995
NOVA MICROSONICS ACCESS IMAGE MANAGEMENT NETWORK/ACCESS ACQUISITION MODULE
K940423 · Advanced Technology Laboratories, Inc. · Jul 1994