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511
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489
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431
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406
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Manufacturers
IT
Qr S.R.L.
Medical Device Manufacturer
·
IT , Verona
Qr S.R.L. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2011
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Qr S.R.L.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Mar 31, 2016
NewTom VGi evo
K151612
·
OAS
Radiology
·
290d
Cleared
Jan 26, 2015
NewTom 5G
K142222
·
JAK
Radiology
·
166d
Cleared
Jul 03, 2013
NEWTOM VGI AND NEWTOM 5G
K130442
·
OAS
Radiology
·
132d
Cleared
Apr 06, 2011
NEWTOM 5G / NEWTOM 5G VERSION FP
K110260
·
OAS
Radiology
·
68d
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Radiology
4