Edge

GUDID 00869126000437

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.

OSKO, INC.

Indirect flat panel x-ray detector

• Primary Device ID: 00869126000437
• NIH Device Record Key: fa1c6f5d-3e1b-49ed-9030-6aec4f302904
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Edge
• Version Model Number: Edge
• Company DUNS: 017527767
• Company Name: OSKO, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(305)599-7161
• Email: info@oskomedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869126000437 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172682

FDA Product Code

• MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-07
• Device Publish Date: 2017-11-16

Devices Manufactured by OSKO, INC.

• 00869126000468 - DCX: 2019-06-18 Stationary X-Ray System
• 00869126000451 - Smart Stitching: 2019-05-23 A software application that allows post-capture positioning and joining of individual images, to produce an additional composite
• 00869126000437 - Edge: 2019-05-07Digital 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.
• 00869126000437 - Edge: 2019-05-07 Digital Flat Panel X-Ray Detector used to generate images of any part of the body. The system consists of a scintillator directl
• 00869126000444 - Edge Air: 2019-05-07 Digital X-Ray flat panel detector used to acquire radiographic images of human anatomy when used with existing radiographic x-ra
• 00869126000406 - RU3000: 2018-07-06 Digital Diagnostic X-Ray System
• 00869126000413 - ELIAN: 2018-07-06 Digital Diagnostic X-Ray System
• 00869126000420 - XR5: 2018-07-06 Diagnostic X-Ray System