Cleared Traditional

K905199 - PACSNET RESEARCH TOOLKIT

K905199 is an FDA 510(k) clearance for PACSNET RESEARCH TOOLKIT, manufactured by Siemens Gammasonics, Inc.. The device is a Class 1 Radiology device with product code LMD cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K905199 · Siemens Gammasonics, Inc. · Radiology device
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Jan 1991
Decision
55d
Days
Class 1
Risk

K905199 is an FDA 510(k) clearance for the PACSNET RESEARCH TOOLKIT. Classified as System, Digital Image Communications, Radiological (product code LMD), Class I - General Controls.

Submitted by Siemens Gammasonics, Inc. (Hoffman Estates, US). The FDA issued a Cleared decision on January 14, 1991 after a review of 55 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 Gammasonics, Inc. devices

FDA 510(k) Submission Details - K905199

510(k) Number K905199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1990
Decision Date January 14, 1991
Days to Decision 55 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 107d · This submission: 55d
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 28
Devices cleared under the same product code (LMD) and FDA review panel - the closest regulatory comparables to K905199.
SIENET ARCHIVE SERVER, ISA I, ISA II STORAGE SERVE
K920310 · Siemens Gammasonics, Inc. · Mar 1992
PHILIPS TELESCAN
K911773 · Philips Medical Systems, Inc. · Jun 1991
KODAK EKTASCAN DIGITAL INTERFACE/FOR AT&T
K911405 · Eastman Kodak Company · Apr 1991
DU PONT LINX LASER IMAGER W/THE LINX NETWORKING
K900935 · E.I. Dupont DE Nemours & Co., Inc. · May 1990
MEDI-TRACE THERMAL VIDEO FILM PAPER
K891192 · Graphic Controls Corp. · Apr 1989
GE INTEGRATED DIAGNOSTIC SYSTEM (DRS.PRS)
K873121 · General Electric Co. · Aug 1988