Cleared Traditional

K934386 - IMPAX 5000

K934386 is the FDA 510(k) clearance for IMPAX 5000 by Heraeus Kulzer, Inc.. It is a Class 1 Radiology device (product code LMD) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K934386 · Heraeus Kulzer, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
119d
Days
Class 1
Risk

K934386 is an FDA 510(k) clearance for the IMPAX 5000. Classified as System, Digital Image Communications, Radiological (product code LMD), Class I - General Controls.

Submitted by Heraeus Kulzer, Inc. (Orangeburg, US). The FDA issued a Cleared decision on January 5, 1994 after a review of 119 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 Heraeus Kulzer, Inc. devices

Submission Details

510(k) Number K934386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1993
Decision Date January 05, 1994
Days to Decision 119 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 107d · This submission: 119d
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 27
Devices cleared under the same product code (LMD) and FDA review panel - the closest regulatory comparables to K934386.
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
KODAK EKTASCAN NETWORK INTERFACE/FOR OTHER MANUFACTURERS
K936116 · Eastman Kodak Company · Apr 1994
IMPAX 1000
K933409 · Heraeus Kulzer, Inc. · Nov 1993
DIGITAL IMAGE COMMUNICATIONS SYSTEM
K933103 · Analogic Corp. · Oct 1993
KODAK EKTASCAN IMAGELINK SYSTEM (KEIS)
K931551 · Eastman Kodak Company · Jun 1993