Konica Minolta Ultra Software - ViZion Ultra is intended for digital image - KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.

Duns Number:080269345

Device Description: ViZion Ultra is intended for digital image capture use in general radiographic examination ViZion Ultra is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion Ultra allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.

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More Product Details

Catalog Number

-

Brand Name

Konica Minolta Ultra Software

Version/Model Number

ULTRA 04-01-00-000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

MQB

Product Code Name

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

Device Record Status

Public Device Record Key

ffc0f328-9724-4c5c-a7c2-cb1803b3d977

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 27, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KONICA MINOLTA MEDICAL IMAGING U.S.A., INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 44