Rayvolve

Radiological Computer Assisted Detection/diagnosis Software For Fracture

AZmed SAS

The following data is part of a premarket notification filed by Azmed Sas with the FDA for Rayvolve.

Pre-market Notification Details

Device IDK220164
510k NumberK220164
Device Name:Rayvolve
ClassificationRadiological Computer Assisted Detection/diagnosis Software For Fracture
Applicant AZmed SAS 6 Rue Leonard De Vinci Laval,  FR 53000
ContactPatricia Massako
CorrespondentPatricia Massako
AZmed SAS 6 Rue Leonard De Vinci Laval,  FR 53000
Product CodeQBS  
CFR Regulation Number892.2090 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-20
Decision Date2022-06-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03770018071022 K220164 000
03770018071015 K220164 000
03770018071008 K220164 000

Trademark Results [Rayvolve]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RAYVOLVE
RAYVOLVE
74103937 1657407 Live/Registered
TE CONNECTIVITY CORPORATION
1990-10-09

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