RADMEDIX, LLC

Address:2510 Lance Rd.,Dayton,OH,45409,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, X-Ray, Mobile (IZL) (5) System, X-Ray, Stationary (KPR) (4) System, Image Processing, Radiological (LLZ) (1)

Premarket Exempt

Clear

AcuityPDR - 00810035220300 Catalog Number :

Device Class : 2

Duns Number: 005057263

Premarket Exempt : No

Product Code : IZL

Prescription Use : No

Device Count : 1

AcuitySDR - 00810035220317 Catalog Number :

Device Class : 2

Duns Number: 005057263

Premarket Exempt : No

Product Code : KPR

Prescription Use : No

Device Count : 1

AcuitySDR - 00810035220324 Catalog Number :

Device Class : 2

Duns Number: 005057263

Premarket Exempt : No

Product Code : KPR

Prescription Use : No

Device Count : 1

AcuityPDR - 00810035220331 Catalog Number :

Device Class : 2

Duns Number: 005057263

Premarket Exempt : No

Product Code : IZL

Prescription Use : No

Device Count : 1

AcuityPDR - 00810035220348 Catalog Number :

Device Class : 2

Duns Number: 005057263

Premarket Exempt : No

Product Code : IZL

Prescription Use : No

Device Count : 1

AcuityPDR - 00810035220355 Catalog Number :

Device Class : 2

Duns Number: 005057263

Premarket Exempt : No

Product Code : IZL

Prescription Use : No

Device Count : 1

AcuityPDR - 00810035220362 Catalog Number :

Device Class : 2

Duns Number: 005057263

Premarket Exempt : No

Product Code : IZL

Prescription Use : No

Device Count : 1

Radmedix AccuVue+ - 00810035220379 Catalog Number :

Device Description : A software application to facilitate management, distribution, and/or viewing of A software application to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data, Including functions for viewing, communication, printing, recording/ disc burning and/or image manipulation.

Device Class : 2

Duns Number: 005057263

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Radmedix AcuityFDR - 00810035220386 Catalog Number :

Device Class : 2

Duns Number: 005057263

Premarket Exempt : No

Product Code : KPR

Prescription Use : No

Device Count : 1

Radmedix AcuityFDR+ - 00810035220393 Catalog Number :

Device Class : 2

Duns Number: 005057263

Premarket Exempt : No

Product Code : KPR

Prescription Use : No

Device Count : 1

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