RayPilot System

Accelerator, Linear, Medical

Micropos Medical AB

The following data is part of a premarket notification filed by Micropos Medical Ab with the FDA for Raypilot System.

Pre-market Notification Details

Device IDK203722
510k NumberK203722
Device Name:RayPilot System
ClassificationAccelerator, Linear, Medical
Applicant Micropos Medical AB Adolf Edelsvards Gata 11 Gothenburg,  SE Se414 51
ContactThomas Lindstrom
CorrespondentHanna Syren
Micropos Medical AB Adolf Edelsvards Gata 11 Gothenburg,  SE Se414 51
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-21
Decision Date2021-09-02

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