QUIBIM Precision Prostate (qp-Prostate)

System, Image Processing, Radiological

QUIBIM S.L.

The following data is part of a premarket notification filed by Quibim S.l. with the FDA for Quibim Precision Prostate (qp-prostate).

Pre-market Notification Details

Device IDK203582
510k NumberK203582
Device Name:QUIBIM Precision Prostate (qp-Prostate)
ClassificationSystem, Image Processing, Radiological
Applicant QUIBIM S.L. Avenida Aragón 30, 12th Floor, Office I, 46021, Valencia (Spain) Valencia,  ES 46021
ContactAngel Alberich Bayarri
CorrespondentJohn J. Smith
Hogan Lovells US LLP 555 13th St NW Washington,  DC  20005
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-07
Decision Date2021-02-04

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