Cleared Traditional

K950513 - ARCHIVEMANAGER

K950513 is an FDA 510(k) clearance for ARCHIVEMANAGER, manufactured by Cemax, Inc.. The device is a Class 1 Radiology device with product code LMD cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K950513 · Cemax, Inc. · Radiology device
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Nov 1995
Decision
280d
Days
Class 1
Risk

K950513 is an FDA 510(k) clearance for the ARCHIVEMANAGER. Classified as System, Digital Image Communications, Radiological (product code LMD), Class I - General Controls.

Submitted by Cemax, Inc. (Fremont, US). The FDA issued a Cleared decision on November 13, 1995 after a review of 280 days - an extended review 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: 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 Cemax, Inc. devices

FDA 510(k) Submission Details - K950513

510(k) Number K950513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1995
Decision Date November 13, 1995
Days to Decision 280 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
173d slower than avg
Panel avg: 107d · This submission: 280d
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 80
Devices cleared under the same product code (LMD) and FDA review panel - the closest regulatory comparables to K950513.
IDXVIEW
K954071 · Idx Systems Corp. · Feb 1996
DICOMVIEW
K954479 · Heartlab, Inc. · Feb 1996
REMOTE VIEWING SYSTEM MEDICAL IMAGE DISPLAY MODULE
K955000 · Cerner Corp. · Jan 1996
SIENET SPI SPOOLER
K953552 · Siemens Medical Solutions USA, Inc. · Oct 1995
DIGITAL IMAGING SYSTEM INTERFACE
K953080 · Camtronics, Ltd. · Sep 1995
MODEM TRANSFER APPLICATION SOFTWARE NSMD-001A & NSMD-070A
K952484 · Toshiba America Medical Systems, In.C · Jun 1995