OSKO, INC.

Address:8085 NW 90th St,Miami,FL,33166,US

Want to know more about this Organization? Request more information now!

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, Stationary (KPR) (4) Solid State X-Ray Imager (Flat Panel/Digital Imager) (MQB) (2) System, Image Processing, Radiological (LLZ) (1)

Premarket Exempt

Clear

RU3000 - 00869126000406 Catalog Number :

Device Description : Digital Diagnostic X-Ray System

Device Class : 2

Duns Number: 017527767

Premarket Exempt : No

Product Code : KPR

Prescription Use : No

Device Count : 1

ELIAN - 00869126000413 Catalog Number :

Device Description : Digital Diagnostic X-Ray System

Device Class : 2

Duns Number: 017527767

Premarket Exempt : No

Product Code : KPR

Prescription Use : No

Device Count : 1

XR5 - 00869126000420 Catalog Number :

Device Description : Diagnostic X-Ray System

Device Class : 2

Duns Number: 017527767

Premarket Exempt : No

Product Code : KPR

Prescription Use : No

Device Count : 1

Edge - 00869126000437 Catalog Number :

Device Description : Digital Flat Panel X-Ray Detector used to generate images of any part of the bod Digital Flat Panel X-Ray Detector used to generate images of any part of the body. The system consists of a scintillator directly coupled to an a-Si TFT sensor. The system generates high-resolution and high-sensitive digital images.

Device Class : 2

Duns Number: 017527767

Premarket Exempt : No

Product Code : MQB

Prescription Use : No

Device Count : 1

Edge Air - 00869126000444 Catalog Number :

Device Description : Digital X-Ray flat panel detector used to acquire radiographic images of human a Digital X-Ray flat panel detector used to acquire radiographic images of human anatomy when used with existing radiographic x-ray systems.

Device Class : 2

Duns Number: 017527767

Premarket Exempt : No

Product Code : MQB

Prescription Use : No

Device Count : 1

Smart Stitching - 00869126000451 Catalog Number :

Device Description : A software application that allows post-capture positioning and joining of indiv A software application that allows post-capture positioning and joining of individual images, to produce an additional composite image for a two-dimensional image review.

Device Class : 2

Duns Number: 017527767

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

DCX - 00869126000468 Catalog Number :

Device Description : Stationary X-Ray System

Device Class : 2

Duns Number: 017527767

Premarket Exempt : No

Product Code : KPR

Prescription Use : No

Device Count : 1

Previous 1 Next