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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Nio Color 3MP LED - 05415334001107

MDNC-3421 NC
Barco NV
MDNC-3421
In Commercial Distribution

  • 05415334001107 ()
K9300341A

  • Radiology picture archiving and communication system workstation

Nio Color 2MP - 05415334000384

MDNC-2123 DE WH
Barco NV
MDNC-2123
In Commercial Distribution

  • 05415334000384 ()
K9300330A

  • Radiology picture archiving and communication system workstation

Nio Color 2MP - 05415334000377

MDNC-2123 EM BL
Barco NV
MDNC-2123
Not in Commercial Distribution

  • 05415334000377 ()
K9300332A

  • Radiology picture archiving and communication system workstation

Nio 3MP LED - 05415334000360

MDNG-3220 W/O FF CN
Barco NV
MDNG-3220
In Commercial Distribution

  • 05415334000360 ()
K9301863A

  • Radiology picture archiving and communication system workstation

Nio 3MP LED - 05415334000353

MDNG-3220 CN
Barco NV
MDNG-3220
In Commercial Distribution

  • 05415334000353 ()
K9301862A

  • Radiology picture archiving and communication system workstation

Nio 3MP LED - 05415334000346

MDNG-3220 W/O FF
Barco NV
MDNG-3220
Not in Commercial Distribution

  • 05415334000346 ()
K9301861A

  • Radiology picture archiving and communication system workstation

Nio 3MP LED - 05415334000339

No Description
Barco NV
MDNG-3220
In Commercial Distribution

  • 05415334000339 ()
K9301860A

  • Radiology picture archiving and communication system workstation

Nio Color 2MP HB - 05415334000322

MDNC-2221 HE MK II
Barco NV
MDNC-2221
Not in Commercial Distribution

  • 05415334000322 ()
K9301653B

  • Radiology picture archiving and communication system workstation

Nio Color 2MP HB - 05415334000315

MDNC-2221 HE
Barco NV
MDNC-2221
Not in Commercial Distribution

  • 05415334000315 ()
K9301653A

  • Radiology picture archiving and communication system workstation

Nio Color 2MP HB - 05415334000308

MDNC-2221 W/O FF MKII
Barco NV
MDNC-2221
In Commercial Distribution

  • 05415334000308 ()
K9301649B

  • Radiology picture archiving and communication system workstation

Nio Color 2MP HB - 05415334000292

MDNC-2221 W/O FF
Barco NV
MDNC-2221
Not in Commercial Distribution

  • 05415334000292 ()
K9301649A

  • Radiology picture archiving and communication system workstation

Nio Color 2MP HB - 05415334000285

MDNC-2221 MKII
Barco NV
MDNC-2221
In Commercial Distribution

  • 05415334000285 ()
K9301648B

  • Radiology picture archiving and communication system workstation

Nio Color 2MP HB - 05415334000278

No Description
Barco NV
MDNC-2221
Not in Commercial Distribution

  • 05415334000278 ()
K9301648A

  • Radiology picture archiving and communication system workstation

Coronis Fusion 6MP LED - 05415334000261

No Description
Barco NV
MDCC-6430
In Commercial Distribution

  • 05415334000261 ()
K9301635A

  • Radiology picture archiving and communication system workstation

Coronis Fusion 6MP LED - 05415334000254

No Description
Barco NV
MDCC-6330
Not in Commercial Distribution

  • 05415334000254 ()
K9301634A

  • Radiology picture archiving and communication system workstation

Coronis Fusion 4MP LED - 05415334000247

No Description
Barco NV
MDCC-4330
In Commercial Distribution

  • 05415334000247 ()
K9301625A

  • Radiology picture archiving and communication system workstation

Coronis Fusion 4MP LED - 05415334000230

No Description
Barco NV
MDCC-4230
Not in Commercial Distribution

  • 05415334000230 ()
K9301615A

  • Radiology picture archiving and communication system workstation

Coronis 5MP - 05415334000223

MDCG-5221 BB GE
Barco NV
MDCG-5221
In Commercial Distribution

  • 05415334000223 ()
K9301542B

  • Radiology picture archiving and communication system workstation

Coronis 5MP - 05415334000216

MDCG-5221 BB GE
Barco NV
MDCG-5221
In Commercial Distribution

  • 05415334000216 ()
K9301542A

  • Radiology picture archiving and communication system workstation

Coronis 5MP - 05415334000209

MDCG-5221 BB
Barco NV
MDCG-5221
In Commercial Distribution

  • 05415334000209 ()
K9301541B

  • Radiology picture archiving and communication system workstation

Coronis 5MP - 05415334000193

MDCG-5221 BB
Barco NV
MDCG-5221
Not in Commercial Distribution

  • 05415334000193 ()
K9301541A

  • Radiology picture archiving and communication system workstation

Coronis 5MP - 05415334000186

MDCG-5221 CB
Barco NV
MDCG-5221
In Commercial Distribution

  • 05415334000186 ()
K9301540B

  • Radiology picture archiving and communication system workstation

Coronis 5MP - 05415334000179

MDCG-5221 CB
Barco NV
MDCG-5221
Not in Commercial Distribution

  • 05415334000179 ()
K9301540A

  • Radiology picture archiving and communication system workstation

Coronis 3MP LED - 05415334000162

No Description
Barco NV
MDCG-3221
In Commercial Distribution

  • 05415334000162 ()


  • Radiology picture archiving and communication system workstation

Barco Mammo Tomosynthesis - 05415334000155

No Description
Barco NV
MDMG-5221
In Commercial Distribution

  • 05415334000155 ()


  • Radiology picture archiving and communication system workstation

Nio 2MP - 05415334000148

No Description
Barco NV
E 2620 S
In Commercial Distribution

  • 05415334000148 ()


  • Radiology picture archiving and communication system workstation

Nio 5.8MP - 05415334000131

MDNC-6121
Barco NV
MDNC-6121
In Commercial Distribution

  • 05415334000131 ()
K9300360A

  • Radiology picture archiving and communication system workstation

Coronis 5MP Mammo - 05415334000124

No Description
Barco NV
MDMG-5121
Not in Commercial Distribution

  • 05415334000124 ()
K9300507B

  • Radiology picture archiving and communication system workstation

Nio 5MP LED - 05415334000117

MDNG-5221 BB
Barco NV
MDNG-5221
In Commercial Distribution

  • 05415334000117 ()
K9300351B

  • Radiology picture archiving and communication system workstation

Nio 5MP LED - 05415334000100

MDNG-5221 BB
Barco NV
MDNG-5221
Not in Commercial Distribution

  • 05415334000100 ()
K9300351A

  • Radiology picture archiving and communication system workstation

Nio 5MP LED - 05415334000094

MDNG-5221 CB
Barco NV
MDNG-5221
In Commercial Distribution

  • 05415334000094 ()
K9300350B

  • Radiology picture archiving and communication system workstation

Nio 5MP LED - 05415334000087

MDNG-5221 CB
Barco NV
MDNG-5221
Not in Commercial Distribution

  • 05415334000087 ()
K9300350A

  • Radiology picture archiving and communication system workstation

Nio Color 3MP LED - 05415334000070

No Description
Barco NV
MDNC-3421
In Commercial Distribution

  • 05415334000070 ()
K9300340A

  • Radiology picture archiving and communication system workstation

Nio Color 3MP LED - 05415334000063

MDNC-3321 HLX
Barco NV
MDNC-3321
Not in Commercial Distribution

  • 05415334000063 ()
K9300328A

  • Radiology picture archiving and communication system workstation

Nio Color 3MP LED - 05415334000049

MDNC-3321 LE
Barco NV
MDNC-3321
Not in Commercial Distribution

  • 05415334000049 ()
K9300325A

  • Radiology picture archiving and communication system workstation

Nio Color 3MP LED - 05415334000032

MDNC-3321 W/O FF
Barco NV
MDNC-3321
Not in Commercial Distribution

  • 05415334000032 ()
K9300324A

  • Radiology picture archiving and communication system workstation

Nio Color 3MP LED - 05415334000025

No Description
Barco NV
MDNC-3321
Not in Commercial Distribution

  • 05415334000025 ()
K9300323A

  • Radiology picture archiving and communication system workstation

Coronis Uniti - 05415334000018

No Description
Barco NV
MDMC-12133
In Commercial Distribution

  • 05415334000018 ()
K9301680A

  • Radiology picture archiving and communication system workstation

Nio Color 2MP - 05415334002357

MDNC-2123 DE WH MKII
Barco NV
MDNC-2123
In Commercial Distribution

  • 05415334002357 ()
K9300330B

  • Radiology picture archiving and communication system workstation

Coronis Fusion 4 MP - 05415334002340

MDCC-4430
Barco NV
MDCC-4430
In Commercial Distribution

  • 05415334002340 ()
K9301626A

  • Radiology picture archiving and communication system workstation

Coronis Fusion 6 MP - 05415334002326

MDCC-6530
Barco NV
MDCC-6530
In Commercial Distribution

  • 05415334002326 ()
K9301636A

  • Radiology picture archiving and communication system workstation

Intuitive Workflow Tools - 05415334002050

accessories for image enhancement in diagnostic displays
Barco NV
2.X.X.X
In Commercial Distribution

  • 05415334002050 ()
K9308260

  • Radiology picture archiving and communication system workstation

Nio Color 2MP - 05415334002029

MDNC-2123 DE WP
Barco NV
MDNC-2123
Not in Commercial Distribution

  • 05415334002029 ()
K9300331A

  • Radiology picture archiving and communication system workstation

Nio Color 2MP - 05415334002005

MDNC-2221 EM
Barco NV
MDNC-2221
In Commercial Distribution

  • 05415334002005 ()
K9301654B

  • Radiology picture archiving and communication system workstation

Nio Color 3MP - 05415334001992

MDNC-3421 EM
Barco NV
MDNC-3421
In Commercial Distribution

  • 05415334001992 ()
K9300347A

  • Radiology picture archiving and communication system workstation

Nio Color 3MP - 05415334001916

MDNC-3421 DE
Barco NV
MDNC-3421
In Commercial Distribution

  • 05415334001916 ()
K9300346A

  • Radiology picture archiving and communication system workstation

Coronis Fusion 6MP LED - 05415334000513

No Description
Barco NV
MDCC-6430
In Commercial Distribution

  • 05415334000513 ()
K9301635B

  • Radiology picture archiving and communication system workstation

CommandEP - 00850013331079

HMD Custom Lens Insert
Sentiar, Inc.
RXL01
In Commercial Distribution

  • 00850013331079 ()


  • Radiology picture archiving and communication system workstation

CommandEP - 00850013331048

HMD
Sentiar, Inc.
HMD02
In Commercial Distribution

  • 00850013331048 ()


  • Radiology picture archiving and communication system workstation

CommandEP - 00850013331031

HMD
Sentiar, Inc.
HMD01
In Commercial Distribution

  • 00850013331031 ()


  • Radiology picture archiving and communication system workstation
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