POWERSERVER, POWERREADER, GATEWAY AND POWERCACHE

System, Image Processing, Radiological

RAMSOFT, INC.

The following data is part of a premarket notification filed by Ramsoft, Inc. with the FDA for Powerserver, Powerreader, Gateway And Powercache.

Pre-market Notification Details

Device IDK052460
510k NumberK052460
Device Name:POWERSERVER, POWERREADER, GATEWAY AND POWERCACHE
ClassificationSystem, Image Processing, Radiological
Applicant RAMSOFT, INC. 16 FOUR SEASONS PLACE SUITE 215 Toronto,  CA M9b 6e5
ContactVijay Ramanathan
CorrespondentVijay Ramanathan
RAMSOFT, INC. 16 FOUR SEASONS PLACE SUITE 215 Toronto,  CA M9b 6e5
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-09-07
Decision Date2005-09-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B359GWR6PRU9GA0 K052460 000
B359GWR6PRU91 K052460 000
B359GWY6PRU910 K052460 000
B359PSPACS6PRU910 K052460 000
B359PSRISPACS6PRU910 K052460 000
B359GWR6PRU90 K052460 000
B359GWY6PRU90 K052460 000
B359PSPACS6PRU90 K052460 000
B359PSRISPACS6PRU90 K052460 000
B359GWR60 K052460 000
B359PSRISPACS6PRU100 K052460 000
B359PSPACS6PRU100 K052460 000
B359GWY6PRU9GA0 K052460 000
B359PSPACS6PRU9GA0 K052460 000
B359PSRISPACS6PRU9GA0 K052460 000
B359PSGWR6PRU110 K052460 000
B359PSGWY6PRU110 K052460 000
B359PSPACS6PRU110 K052460 000
B359PSRISPACS6PRU110 K052460 000
B359GWR6PRU100 K052460 000
B359GWY6PRU100 K052460 000
B359GWR6PRU510 K052460 000
B359GWR6PRU60 K052460 000
B359PSPACS6PRU60 K052460 000
B359PSPACS6PRU70 K052460 000
B359PSPACS6PRU720 K052460 000
B359PSPACS6PRU80 K052460 000
B359PSRISPACS60 K052460 000
B359PSRISPACS6PRU510 K052460 000
B359PSRISPACS6PRU60 K052460 000
B359PSRISPACS6PRU70 K052460 000
B359PSRISPACS6PRU720 K052460 000
B359PSPACS6PRU510 K052460 000
B359PSPACS60 K052460 000
B359GWR6PRU70 K052460 000
B359GWR6PRU720 K052460 000
B359GWR6PRU80 K052460 000
B359GWY60 K052460 000
B359GWY6PRU510 K052460 000
B359GWY6PRU60 K052460 000
B359GWY6PRU70 K052460 000
B359GWY6PRU720 K052460 000
B359GWY6PRU80 K052460 000
B359PSRISPACS6PRU80 K052460 000

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