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510(k) K042733

Device
STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM
Applicant
STANDARD IMAGING, INC.
510(k) number
K042733
Product code
LHO  
Decision
Substantially Equivalent (SESE)
Decision date
2004-11-15
Date received
2004-10-01
Regulation
892.1940
Classification name
Instrument, Quality-assurance, Radiologic
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
RAYMOND RIDDLE
Address
7601 Murphy Dr. Middleton WI US 53562 53562

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LHO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K873956ULTIMETERRadiation Measurements, Inc.1987-10-30
K853754MAGNETIC RESONANCE IMAGING UNIFORMITY/T1 76-901Victoreen, Inc.1986-05-07
K860260MULTI PURPOSE MODEL 76-903Victoreen, Inc.1986-05-07
K860100MRI SLICE THICKNESS & CONTIGUITY PHANTOM #76-902Victoreen, Inc.1986-04-22
K844620BDS-3 BEAM DATA SCANNERVarian Assoc., Inc.1985-07-01
K845007RFA-7 RADIATION FIELD ANALYZERVarian Assoc., Inc.1985-07-01
K834483DIGI-XRadiation Measurements, Inc.1984-03-05

Legacy Summary#

summary

FDA Review#

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