DR 600

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

AGFA HEALTHCARE N.V.

The following data is part of a premarket notification filed by Agfa Healthcare N.v. with the FDA for Dr 600.

Pre-market Notification Details

Device IDK152639
510k NumberK152639
Device Name:DR 600
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant AGFA HEALTHCARE N.V. SEPTESTRAAT 27 Mortsel,  BE B 2640
ContactKoren Vervoort
CorrespondentShaeann Cavanagh
AGFA HEALTHCARE CORP. 10 SOUTH ACADEMY STREET Greenville,  SC  29601
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-15
Decision Date2015-12-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05414904197202 K152639 000
05414904196298 K152639 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.