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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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Enterprise Imaging Desktops - 05400874000703

Enterprise Imaging Desktops 8.x
Agfa HealthCare NV
8
In Commercial Distribution



  • Radiological PACS software

Reality DTx - 05065012458121

A software-only medical device intended to improve functional mobility in states of physical impairment caused by neurological conditions such as Parkinson’s disease. The software provides visual and auditory stimuli and gamified rehabilitation exercises through a wearable augmented reality headset to engage and motivate adult patients to perform physical exercises under the direction of the physician in charge.
STROLLL LIMITED
HL2 v6
In Commercial Distribution

CX-HL2-0001

  • Neuromuscular rehabilitation software

Reality DTx - 05065012458114

A software-only medical device intended to improve functional mobility in states of physical impairment caused by neurological conditions such as Parkinson’s disease. The software provides visual and auditory stimuli and gamified rehabilitation exercises through a wearable augmented reality headset to engage and motivate adult patients to perform physical exercises under the direction of the physician in charge.
STROLLL LIMITED
ML2 v6
In Commercial Distribution

CX-ML2-0001

  • Neuromuscular rehabilitation software

Reality DTx - 05065012458046

A software-only medical device intended to improve functional mobility in states of physical impairment caused by neurological conditions such as Parkinson’s disease. The software provides visual and auditory stimuli and gamified rehabilitation exercises through a wearable augmented reality headset to engage and motivate adult patients to perform physical exercises under the direction of the physician in charge.
STROLLL LIMITED
HL2
Not in Commercial Distribution

  • 05065012458046 ()
CX-HL2-0001

  • Neuromuscular rehabilitation software

Reality DTx - 05065012458039

A software-only medical device intended to improve functional mobility in states of physical impairment caused by neurological conditions such as Parkinson’s disease. The software provides visual and auditory stimuli and gamified rehabilitation exercises through a wearable augmented reality headset to engage and motivate adult patients to perform physical exercises under the direction of the physician in charge.
STROLLL LIMITED
ML2
Not in Commercial Distribution

  • 05065012458039 ()
CX-ML2-0001

  • Neuromuscular rehabilitation software

DAS-RS1 - 04573596213759

ULTRASOUND DATA ANALYSIS SYSTEM
FUJIFILM HEALTHCARE CORPORATION
DAS-RS1
In Commercial Distribution



  • Radiological PACS software

ImagePilot - 04560141949584

No Description
KONICA MINOLTA, INC.
V1.93R00E
In Commercial Distribution

  • 04560141949584 ()


  • Radiological PACS software

ImagePilot - 04560141949492

No Description
KONICA MINOLTA, INC.
V1.92R00E
In Commercial Distribution

  • 04560141949492 ()


  • Radiological PACS software

ImagePilot - 04560141944961

No Description
KONICA MINOLTA, INC.
D9MA
In Commercial Distribution

  • 04560141944961 ()


  • Radiological PACS software

ImagePilot - 04560141950399

No Description
KONICA MINOLTA, INC.
V1.95
In Commercial Distribution

  • 04560141950399 ()


  • Radiological PACS software
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