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510(k) K864955

Device
CYTOSCAN
Applicant
IMAGE RECOGNITION SYSTEMS LTD.
510(k) number
K864955
Product code
LNJ  
Decision
Substantially Equivalent (SESE)
Decision date
1987-03-16
Date received
1986-12-18
Regulation
864.5260
Classification name
Analyzer, Chromosome, Automated
Medical specialty
Hematology
Review panel
Pathology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOHN T STOPFORD
Address
720 Birchwood Blvd., Birchwood Warrington, Cheshire GB WA3 7PX WA3 7PX

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LNJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K050236FISHVIEWApplied Spectral Imaging , Ltd.2005-06-27
K012103BANDVIEW SYSTEMApplied Spectral Imaging , Ltd.2001-09-14
K940240IKAROSMetasystems GmbH1995-02-24
K912085ACLAIMS-ISW-Technology1991-10-31
K902311GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO.Applied Imaging Corp.1990-08-20
K895095AKS IIAmoco Technology Co.1990-02-09
K872755KARYOTEC 100Amcor Electronics, Ltd.1987-09-01
K861974PERCEPTIVE SYSTEMS INC PSICOM 217 KARYOTYPING SYSTPerceptive Systems, Inc.1986-08-04
K851508NIKON/JOYCE LOCK MAGICAN 2 CHROMOSOME SYSNikon, Inc.1985-07-12
K851174METACHROMEPotomac Medical System1985-05-23

Legacy Summary#

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FDA Review#

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