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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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Barco Mammo Tomosynthesis - 05415334001565

MDMG-5221
Barco NV
MDMG-5221
Not in Commercial Distribution

  • 05415334001565 ()
K9300520B

  • Radiology picture archiving and communication system workstation

Coronis 5MP - 05415334001558

No Description
Barco NV
MDCG-5121
Not in Commercial Distribution

  • 05415334001558 ()
K9301500B

  • Radiology picture archiving and communication system workstation

Barco Mammo Tomosynthesis - 05415334001534

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

  • 05415334001534 ()
K9300521A

  • Radiology picture archiving and communication system workstation

Barco Mammo Tomosynthesis - 05415334001527

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

  • 05415334001527 ()
K9300520A

  • Radiology picture archiving and communication system workstation

Coronis Fusion 4MP - 05415334001510

No Description
Barco NV
MDCC-4130
Not in Commercial Distribution

  • 05415334001510 ()
K9301605A

  • Radiology picture archiving and communication system workstation

Coronis Fusion 10MP - 05415334001497

No Description
Barco NV
MDCG-10130
Not in Commercial Distribution

  • 05415334001497 ()
K9301660A

  • Radiology picture archiving and communication system workstation

NIO 5MP - 05415334001459

MDNG-5121 BB MA MKII
Barco NV
MDNG-5121
Not in Commercial Distribution

  • 05415334001459 ()
K9300267C

  • Radiology picture archiving and communication system workstation

Nio 3MP - 05415334001442

E-3620 MA LORAD G
Barco NV
E-3620
Not in Commercial Distribution

  • 05415334001442 ()
K9300289D

  • Radiology picture archiving and communication system workstation

Nio 3MP - 05415334001435

E-3620 MA
Barco NV
E-3620
Not in Commercial Distribution

  • 05415334001435 ()
K9300248B

  • 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 - 05415334000209

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

  • 05415334000209 ()
K9301541B

  • 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 3MP LED - 05415334000162

No Description
Barco NV
MDCG-3221
In Commercial Distribution

  • 05415334000162 ()


  • Radiology picture archiving and communication system workstation

Nio Color 2MP - 05415334002623

MDNC-2123 NEU MKII
Barco NV
MDNC-2123
Not in Commercial Distribution

  • 05415334002623 ()
K9300333B

  • Radiology picture archiving and communication system workstation

Nio Color 2MP - 05415334002616

MDNC-2123 EM BL MKII
Barco NV
MDNC-2123
In Commercial Distribution

  • 05415334002616 ()
K9300332B

  • Radiology picture archiving and communication system workstation

Nio Color 2MP - 05415334002609

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

  • 05415334002609 ()
K9300331B

  • 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

MDNG-5121 CB (MA) - 05415334001541

MDNG-5121 CB (MA)
Barco NV
MDNG-5121
Not in Commercial Distribution

  • 05415334001541 ()
K9300266C

  • Radiology picture archiving and communication system workstation

Coronis 5MP Mammo - 05415334001503

No Description
Barco NV
MDMG-5121
Not in Commercial Distribution

  • 05415334001503 ()
K9300507A

  • Radiology picture archiving and communication system workstation

Nio 5MP - 05415334001480

No Description
Barco NV
MDNG-6121
Not in Commercial Distribution

  • 05415334001480 ()
K9301650A

  • Radiology picture archiving and communication system workstation

NIO 5MP - 05415334001473

MDNG-5121 BB MA GE BUC MKII
Barco NV
MDNG-5121
Not in Commercial Distribution

  • 05415334001473 ()
K9300268B

  • Radiology picture archiving and communication system workstation

NIO 5MP - 05415334001466

MDNG-5121 MKII
Barco NV
MDNG-5121
Not in Commercial Distribution

  • 05415334001466 ()
K9300321A

  • Radiology picture archiving and communication system workstation

Nio Color 5MP - 05415334001138

MDNC-6121 NC
Barco NV
MDNC-6121
In Commercial Distribution

  • 05415334001138 ()
K9300361A

  • Radiology picture archiving and communication system workstation

Nio Color 3MP LED - 05415334001121

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

  • 05415334001121 ()
K9300343A

  • Radiology picture archiving and communication system workstation

Nio Color 3MP LED - 05415334001114

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

  • 05415334001114 ()
K9300342A

  • Radiology picture archiving and communication system workstation

Nio Color 3MP LED - 05415334001107

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

  • 05415334001107 ()
K9300341A

  • 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

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
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