DELWORKS DR SYSTEM

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

DEL MEDICAL, INC.

The following data is part of a premarket notification filed by Del Medical, Inc. with the FDA for Delworks Dr System.

Pre-market Notification Details

Device IDK140825
510k NumberK140825
Device Name:DELWORKS DR SYSTEM
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant DEL MEDICAL, INC. 8870 RAVELLO CT Naples,  FL  34114
ContactDaniel Kamm
CorrespondentDaniel Kamm
U.M.G. Inc. / Del Medical, Inc. 8870 RAVELLO CT Naples,  FL  34114
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-04-01
Decision Date2014-07-17
Summary:summary

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