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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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N/A - 04961333236763

HL7 INTERFACE OUTBOUND
PENTAX OF AMERICA, INC.
9269
In Commercial Distribution

  • 04961333236763 ()


  • Radiology information system

N/A - 04961333236756

HL7 INTERFACE INBOUND
PENTAX OF AMERICA, INC.
9267
In Commercial Distribution

  • 04961333236756 ()


  • Radiology information system

N/A - 04961333236749

ENDOPORTAL UPGRADE
PENTAX OF AMERICA, INC.
9265
In Commercial Distribution

  • 04961333236749 ()


  • Radiology information system

N/A - 04961333236732

ENDOPORTAL
PENTAX OF AMERICA, INC.
9263
In Commercial Distribution

  • 04961333236732 ()


  • Radiology information system

N/A - 04961333236725

DICOM INTERFACE FOR STROBE
PENTAX OF AMERICA, INC.
9251
In Commercial Distribution

  • 04961333236725 ()


  • Radiology information system

N/A - 04961333236701

DICOM INTERFACE FOR SWALLOWING
PENTAX OF AMERICA, INC.
7251
In Commercial Distribution

  • 04961333236701 ()


  • Radiology information system

ENDOPRO IQ - 04961333243556

ENDOPRO IQ AMBULATORY SITE LICENSE
PENTAX OF AMERICA, INC.
M70208-UP
In Commercial Distribution

  • 04961333243556 ()


  • Radiology information system

ENDOPRO IQ - 04961333243518

ENDOPRO IQ CAPTURE LICENSE
PENTAX OF AMERICA, INC.
M70206-UP
In Commercial Distribution

  • 04961333243518 ()


  • Radiology information system

N/A - 04961333243211

HD DVI IMAGE CAPTURE PC
PENTAX OF AMERICA, INC.
KBM68403
In Commercial Distribution

  • 04961333243211 ()


  • Radiology information system

N/A - 04961333243204

IMAGE CAPTURE PC
PENTAX OF AMERICA, INC.
KBM68401
Not in Commercial Distribution

  • 04961333243204 ()


  • Radiology information system

N/A - 04961333243181

ASSY: SERVER, TOWER FORM FACTOR
PENTAX OF AMERICA, INC.
KBM68311
In Commercial Distribution

  • 04961333243181 ()


  • Radiology information system

N/A - 04961333242269

CBL,RJ45-RJ45,10,TP
PENTAX OF AMERICA, INC.
92052/10
In Commercial Distribution

  • 04961333242269 ()

  • Length: 10.0 Feet


  • Radiology information system

N/A - 04961333242245

S-VIDEO CABLE
PENTAX OF AMERICA, INC.
92026/6
In Commercial Distribution

  • 04961333242245 ()

  • Length: 6.0 Feet


  • Radiology information system

i.Terminal 2 Station - 04250668606700

N/A
Carl Zeiss Vision GmbH
000000-2433-519
In Commercial Distribution

  • 04250668606700 ()
000000-2433-519

  • Medical image management system

VISUFIT 1000 Platform - 04250668606663

N/A
Carl Zeiss Vision GmbH
000000-2194-446
In Commercial Distribution

  • 04250668606663 ()
000000-2194-446

  • Medical image management system

Upgrade Kit XA60A - 04056869984681

No Description
Siemens Healthcare GmbH
11689973
In Commercial Distribution

  • 04056869984681 ()


  • MRI system application software

Body Spine Array S MR Coil Kit - 04056869049663

Contains Medical Device Mat. 8635547 (GTIN:04056869038780)
Siemens Shenzhen Magnetic Resonance Ltd.
10019287
In Commercial Distribution

  • 04056869049663 ()


  • Full-body MRI system, permanent magnet

Head Array MR Coil Kit - 04056869049656

Contains Medical Device Mat. 8635554 (GTIN:04056869038797)
Siemens Shenzhen Magnetic Resonance Ltd.
10019258
In Commercial Distribution

  • 04056869049656 ()


  • Full-body MRI system, permanent magnet

syngo.MR Neurology - 04056869043173

SW Version VB20
Siemens Healthcare GmbH
11291459
In Commercial Distribution

  • 04056869043173 ()


  • MRI system application software

syngo.MR General - 04056869043159

SW Version VB20
Siemens Healthcare GmbH
11291457
In Commercial Distribution

  • 04056869043159 ()


  • MRI system application software

syngo.SPECT Processing - 04056869027470

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11218249
In Commercial Distribution

  • 04056869027470 ()


  • SPECT system application software

MAGNETOM C! - 04056869020495

MRI Scanner
Siemens Shenzhen Magnetic Resonance Ltd.
10498833
In Commercial Distribution

  • 04056869020495 ()


  • Full-body MRI system, permanent magnet

syngo.MR Oncology - 04056869012834

SW version VB10B
Siemens Healthcare GmbH
11234873
In Commercial Distribution

  • 04056869012834 ()


  • MRI system application software

Viewer - 04056481143800

No Description
Brainlab AG
5.3
In Commercial Distribution

  • 04056481143800 ()


  • Medical image management system

Elements Viewer - 04056481143619

No Description
Brainlab AG
5.2
In Commercial Distribution

  • 04056481143619 ()


  • Medical image management system

Buzz 2.0 - 04056481143305

No Description
Brainlab AG
15800A
In Commercial Distribution

  • 04056481143305 ()


  • Medical image management system

Buzz Virtual - 04056481143046

No Description
Brainlab AG
15501
In Commercial Distribution

  • 04056481143046 ()


  • Medical image management system

Buzz Compact - 04056481143039

No Description
Brainlab AG
15790
In Commercial Distribution

  • 04056481143039 ()


  • Medical image management system

Viewer - 04056481142513

No Description
Brainlab AG
5.1
In Commercial Distribution

  • 04056481142513 ()


  • Medical image management system

Brainlab Elements Fibertracking - 04056481142186

No Description
Brainlab AG
2.0
In Commercial Distribution

  • 04056481142186 ()


  • Radiological PACS software
  • Stereotactic system application software
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