DYNAPBV BODY SOFTWARE

System, Image Processing, Radiological

SIEMENS MEDICAL SOLUTIONS USA, INC.

The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Dynapbv Body Software.

Pre-market Notification Details

Device IDK121292
510k NumberK121292
Device Name:DYNAPBV BODY SOFTWARE
ClassificationSystem, Image Processing, Radiological
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern,  PA  19355 -1406
ContactPatricia D Jones
CorrespondentPatricia D Jones
SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern,  PA  19355 -1406
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-04-30
Decision Date2012-07-30
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.