PRIMO S

Solid State X-ray Imager (flat Panel/digital Imager)

A.T.S. Applicazione Tecnologie Speciali S.R.L.

The following data is part of a premarket notification filed by A.t.s. Applicazione Tecnologie Speciali S.r.l. with the FDA for Primo S.

Pre-market Notification Details

Device IDK211542
510k NumberK211542
Device Name:PRIMO S
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant A.T.S. Applicazione Tecnologie Speciali S.R.L. Via Alessandro Volta, 10 Torre De Roveri,  IT 24060
ContactLivia Pillitteri
CorrespondentDaniel Kamm
Kamm & Associates 8870 Ravello Ct Naples,  FL  34114
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-19
Decision Date2021-07-09

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