Cleared Traditional

K960809 - PHILIPS SITE VIEW WORKSTATION (FDA 510(k) Clearance)

K960809 · Philips Medical Systems North America, Inc. · Radiology device

Apr 1996

Decision

39d

Days

Class 1

Risk

K960809 is an FDA 510(k) clearance for the PHILIPS SITE VIEW WORKSTATION. This device is classified as a System, Digital Image Communications, Radiological (Class I - General Controls, product code LMD).

Submitted by Philips Medical Systems North America, Inc. (Shelton, US). The FDA issued a Cleared decision on April 7, 1996, 39 days after receiving the submission on February 28, 1996.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2020. 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..

Submission Details

510(k) Number	K960809 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 28, 1996
Decision Date	April 07, 1996
Days to Decision	39 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	LMD — System, Digital Image Communications, Radiological
Device Class	Class I - 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.