Cleared Traditional

AD/V IMAGEPLEX(TM) (K943158) - FDA 510(k) Clearance

Class I Radiology device.

K943158 · Adaptive Video, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
144d
Days
Class 1
Risk

K943158 is an FDA 510(k) clearance for the AD/V IMAGEPLEX(TM). Classified as System, Digital Image Communications, Radiological (product code LMD), Class I - General Controls.

Submitted by Adaptive Video, Inc. (Novato, US). The FDA issued a Cleared decision on November 22, 1994 after a review of 144 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Adaptive Video, Inc. devices

Submission Details

510(k) Number K943158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1994
Decision Date November 22, 1994
Days to Decision 144 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
37d slower than avg
Panel avg: 107d · This submission: 144d
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.

Regulatory Peers - LMD System, Digital Image Communications, Radiological

All 17
Devices cleared under the same product code (LMD) and FDA review panel - the closest regulatory comparables to K943158.
KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGER
K960382 · Eastman Kodak Company · 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
KODAK EKTASCAN NETWORK INTERFACE/FOR OTHER MANUFACTURERS
K936116 · Eastman Kodak Company · Apr 1994
IMPAX 5000
K934386 · Heraeus Kulzer, Inc. · Jan 1994
IMPAX 1000
K933409 · Heraeus Kulzer, Inc. · Nov 1993