← Back to catalogue

SkyVision

FDA UDI

Class I (US FDA UDI)

by Skytron, LLC

Identity

Trade Name
SkyVision FDA UDI
Generic Name
Radiology picture archiving and communication system digital archive device FDA UDI
Device Name
SkyVision LINX 300 Digital Integration system includes: Medical Grade Touch Panel, Optical Router, IP addressable Control Switch and On-Board Uninterruptable Power Supply. FDA UDI
Model / Reference
LINX 300 FDA UDI
Description
SkyVision LINX 300 Digital Integration system includes: Medical Grade Touch Panel, Optical Router, IP addressable Control Switch and On-Board Uninterruptable Power Supply. FDA UDI

Identifiers

Catalog Number
SVIS-LINX FDA UDI
Primary DI / UDI-DI
10841736111724 FDA UDI
FDA Product Code
LMD FDA UDI
GMDN Term
Radiology picture archiving and communication system digital archive device FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.2020 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Radiology picture archiving and communication system digital archive device

SkyVision by Skytron, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiology picture archiving and communication system digital archive device.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Skytron, LLC

Sources (1)

  • FDA UDI 7c96f135-abbe-4444-add8-3fb1733535cc 35 fields · synced May 30, 2026