DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE)

System, Image Processing, Radiological

INVIVO CORPORATION

The following data is part of a premarket notification filed by Invivo Corporation with the FDA for Dynacad/prostate Interventional (dynaloc/prostate).

Pre-market Notification Details

Device IDK133030
510k NumberK133030
Device Name:DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE)
ClassificationSystem, Image Processing, Radiological
Applicant INVIVO CORPORATION 3545 SW 47TH AVE. Gainesville,  FL  32608
ContactLisa Simpson
CorrespondentLisa Simpson
INVIVO CORPORATION 3545 SW 47TH AVE. Gainesville,  FL  32608
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-09-26
Decision Date2014-01-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838082885 K133030 000

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