ProstatID

Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer

ScanMed, LLC

The following data is part of a premarket notification filed by Scanmed, Llc with the FDA for Prostatid.

Pre-market Notification Details

Device IDK212783
510k NumberK212783
Device Name:ProstatID
ClassificationRadiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer
Applicant ScanMed, LLC 9840 S 140 Street, Suite #8 Omaha,  NE  68138
ContactRandall Jones
CorrespondentCarlee Seeba
ScanMed, LLC 9840 S 140 Street, Suite #8 Omaha,  NE  68138
Product CodeQDQ  
CFR Regulation Number892.2090 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-01
Decision Date2022-07-08

Trademark Results [ProstatID]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PROSTATID
PROSTATID
90324153 not registered Live/Pending
Bot Image, Inc.
2020-11-17

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