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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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EMAS (Eko Murmur Analysis Software) - 00850010298184

The Eko Murmur Analysis Software is intended to provide decision support to clinicians in their evaluation of patients’ heart sounds. The software analyzes heart sounds and phonocardiograms (and ECG signals, when available). The software will automatically detect murmurs that may be present, and the murmur timing and character, including S1, S2, innocent heart murmurs, structural heart murmurs, and the absence of a heart murmur.
Eko Devices, Inc.
Version 1.x
In Commercial Distribution

  • 00850010298184 ()
EMAS

  • Cardiopulmonary physiological parameter analysis software

OncoMate MSI Dx Interpretive Software - 00849811056857

Software used to interpret data obtained using the OncoMate MSI Dx Analysis System.
PROMEGA CORPORATION
MD4140
In Commercial Distribution

  • 00849811056857 ()
MD4140

  • Microsatellite instability IVD, kit, nucleic acid technique (NAT)

ENDOCAPSULE SOFTWARE 10 SOFT SERVER-CLIENT - 04953170360817

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2038
Not in Commercial Distribution

  • 04953170360817 ()
N5368840

  • Video capsule endoscopy system application software

ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGE - 04953170373848

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2190
In Commercial Distribution

  • 14953170373845 ()
  • 04953170373848 ()
N5400540

  • Video capsule endoscopy system application software

ARIA Radiation Therapy Management Software - 00856100006127

No Description
Varian Medical Systems Imaging Laboratory GmbH
16.0
In Commercial Distribution

  • 00856100006127 ()


  • Radiation therapy treatment record/verify system

ARIA Radiation Therapy Management Software - 00856100006110

No Description
Varian Medical Systems Imaging Laboratory GmbH
15.6
In Commercial Distribution

  • 00856100006110 ()


  • Radiation therapy treatment record/verify system

ARIA Radiation Therapy Management Software - 00856100006097

No Description
Varian Medical Systems Imaging Laboratory GmbH
15.5
In Commercial Distribution

  • 00856100006097 ()


  • Radiation therapy treatment record/verify system

ARIA Radiation Therapy Management Software - 00856100006080

No Description
VARIAN MEDICAL SYSTEMS, INC.
15.1
In Commercial Distribution

  • 00856100006080 ()


  • Radiation therapy treatment record/verify system

ARIA Radiation Therapy Management Software - 00856100006073

No Description
VARIAN MEDICAL SYSTEMS, INC.
13.7
In Commercial Distribution

  • 00856100006073 ()


  • Radiation therapy treatment record/verify system

ARIA Radiation Therapy Management Software - 00856100006066

No Description
VARIAN MEDICAL SYSTEMS, INC.
13.6
In Commercial Distribution

  • 00856100006066 ()


  • Radiation therapy treatment record/verify system
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