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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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AWARE - 00850893007019

Clinical decision support software indicated for use by licensed clinicians in a clinical setting integrated with Philips ICCA product.
AMBIENT CLINICAL ANALYTICS, INC.
P1.0
In Commercial Distribution

  • 00850893007019 ()


  • Clinical management support software

AWARE - 00850893007002

No Description
AMBIENT CLINICAL ANALYTICS, INC.
1.1
In Commercial Distribution

  • 00850893007002 ()


  • Clinical management support software

AWARE DART - 00850893007026

Clinical decision support software for disease detection and response indicated for use by licensed clinicians in a clinical setting.
AMBIENT CLINICAL ANALYTICS, INC.
1.1
In Commercial Distribution

  • 00850893007026 ()


  • Clinical management support software

cvi42 - 00882916000011

No Description
Circle Cardiovascular Imaging Inc
5.x
In Commercial Distribution

  • 00882916000011 ()


  • MRI system application software

HexaVue - 00724995220594

HexaVue IP In-Light Camera Control Feature
BLACK DIAMOND VIDEO, INC.
HexaVue IP
In Commercial Distribution

  • 00724995220594 ()
XQHPILCC

  • Operating room audiovisual data/device management system application software

HexaVue - 00724995220587

HexaVue IP Surgical Light Control Feature
BLACK DIAMOND VIDEO, INC.
HexaVue IP
In Commercial Distribution

  • 00724995220587 ()
XQHPSLC

  • Operating room audiovisual data/device management system application software

NA - 00724995163723

The IDSS-SLC Version 8 OR Integration software module allows the remote control of surgical lights during a surgical procedure and the software provides support for routing higher resolution 4K video when used with supporting 4K routing hardware installed in the BDV IDSS integration system.
BLACK DIAMOND VIDEO, INC.
IDSS-SLC Version 8
Not in Commercial Distribution

  • 00724995163723 ()
XQSLC1

  • Operating room audiovisual data/device management system application software

NA - 00724995153083

The IDSS-SLC Version 7 OR Integration software module allows the remote control of surgical lights during a surgical procedure.
BLACK DIAMOND VIDEO, INC.
IDSS-SLC
Not in Commercial Distribution

  • 00724995153083 ()
XQSLC1

  • Operating room audiovisual data/device management system application software

NA - 00724995152031

OR Integration software module Version 6 that allows the remote control of surgical lights during a surgical procedure.
BLACK DIAMOND VIDEO, INC.
IDSS-SLC
Not in Commercial Distribution

  • 00724995152031 ()


  • Operating room audiovisual data/device management system application software

Harmony iQ - 00724995199142

The Surgical Light Control and Surgical Camera Control for the Harmony IQ 3600 Integration Systems promotes efficient and prompt reaction to procedure events.
BLACK DIAMOND VIDEO, INC.
Harmony iQ 3600
Not in Commercial Distribution

  • 00724995199142 ()
RLQ3600SLC

  • Operating room audiovisual data/device management system application software
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