Cleared Traditional

K950699 - PREVIEW TELEIMAGING SYSTEM

K950699 is an FDA 510(k) clearance for PREVIEW TELEIMAGING SYSTEM, manufactured by Regulatory Management Services. The device is a Class 1 Radiology device with product code LMD cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K950699 · Regulatory Management Services · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
77d
Days
Class 1
Risk

K950699 is an FDA 510(k) clearance for the PREVIEW TELEIMAGING SYSTEM. Classified as System, Digital Image Communications, Radiological (product code LMD), Class I - General Controls.

Submitted by Regulatory Management Services (San Leandro, US). The FDA issued a Cleared decision on May 3, 1995 after a review of 77 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.

FDA 510(k) Submission Details - K950699

510(k) Number K950699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1995
Decision Date May 03, 1995
Days to Decision 77 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 107d · This submission: 77d
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 140
Devices cleared under the same product code (LMD) and FDA review panel - the closest regulatory comparables to K950699.
MODEM TRANSFER APPLICATION SOFTWARE NSMD-001A & NSMD-070A
K952484 · Toshiba America Medical Systems, In.C · Jun 1995
PACS EQUIPMENT
K943994 · Rstar Image Management System · May 1995
LOSSLESS TELERADIOLOGY OPTION FOR USE WITH IES, IMAGE ENHANCEMENT SYSTEM
K950431 · Open Mri, Inc. · May 1995
HYPERPACS PACS AND TELERAFIOLOGY SYSTEM
K950343 · Rogan Imaging Corp. · Apr 1995
AT&T IMAGE SOLUTIONS PICASSO STILL-IMAGE PHONE SYSTEM
K944322 · At&T Image Solutions · Feb 1995
IMAGE TRANSPORT SERIES III
K925964 · Dataview Imaging Intl., Inc. · Feb 1995
K950699 · PREVIEW TELEIMAGING SYSTEM
Download PDF FDA Summary Regulatory Management…