ScandiDos Delta4 Phantom+

Accelerator, Linear, Medical

SCANDIDOS AB

The following data is part of a premarket notification filed by Scandidos Ab with the FDA for Scandidos Delta4 Phantom+.

Pre-market Notification Details

Device IDK151180
510k NumberK151180
Device Name:ScandiDos Delta4 Phantom+
ClassificationAccelerator, Linear, Medical
Applicant SCANDIDOS AB DAG HAMMARSKJOLDS VAG 52A Uppsala,  SE Se-75237
ContactThomas Matzen
CorrespondentThomas Matzen
SCANDIDOS AB DAG HAMMARSKJOLDS VAG 52A Uppsala,  SE Se-75237
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-05-04
Decision Date2015-08-19
Summary:summary

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