Video Analyzer 4000

FDA 510(k) K874750 · Scientific Imaging, Inc.

Substantially Equivalent

510(k) numberK874750

Submission

Device name
Video Analyzer 4000
Applicant
Scientific Imaging, Inc.
Fairfield, CT, US
Received
November 18, 1987
Decision date
April 25, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IBJ – Light, Microscope
Device class
Class I (low risk)
Regulation
21 CFR 864.3600
Specialty
Pathology

Other 510(k)s with product code IBJ

510(k)DeviceApplicantDecision
K874207The Purple Iris(Tm) Cytopathology WorkstationIBJ · Traditional Intl. Remote Imaging Systems01/05/1988SE
K874190Cell Counting Grid GraticuleIBJ · Traditional Portable Medical Laboratories, Inc.01/05/1988SE
K864049Mcarthur Microscope, Standard Metal VersionIBJ · Traditional Portable Medical Laboratories, Inc.10/29/1986SE
K854735Mcarthur Microscope Plastic Version with Acc.IBJ · Traditional Portable Medical Laboratories, Inc.12/10/1985SE
K823040Pathology Instrumentation & AccessoriesIBJ · Traditional Iris Remote Imaging Systems01/14/1983SE
K8222072XC MicroscopeIBJ · Traditional Amarel Precision Instruments, Inc.08/05/1982SE
K821865A O Microscope Video SystemIBJ · Traditional Warner-Lambert Co.07/14/1982SE
K802818Pullen Pocket ScopeIBJ · Traditional P.A. Research Corp.04/17/1981SE

More from P.A. Research Corp.

510(k)DeviceDecision
K052904Virtual Medical Systems Model VT3000JXE · Traditional 10/27/2005SE
K900773Nuclear MaxIYX · Traditional 05/23/1990SE

Questions and answers

When was Video Analyzer 4000 cleared by the FDA?

Video Analyzer 4000 (K874750) received a 510(k) decision of Substantially Equivalent on April 25, 1988, 159 days after the submission was received.

What is the product code of K874750?

The FDA product code is IBJ – Light, Microscope, a Class I (low risk) device regulated under 21 CFR 864.3600.