Joints - The Medstrat Joints system is intended to enable - MEDSTRAT, INC.

Duns Number:152206371

Device Description: The Medstrat Joints system is intended to enable the communication, storage, viewing, and The Medstrat Joints system is intended to enable the communication, storage, viewing, and manipulation of diagnostic medical images and data. The Joints system can show images on workstations locally and/or across computer networks at widely distributed locations. The Joints software is intended for assisting healthcare professionals in preoperative planning and postoperative evaluation of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and positioning the templates. The typical Joints users are trained professionals such as orthopedic surgeons, referring and collaborating physicians, and authorized medical professionals.It is the user's responsibility to bear in mind the display monitor's quality, ambient light conditions, and the tradeoff between image compression ratio and clinical effectiveness for specific image study indications.

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More Product Details

Catalog Number

-

Brand Name

Joints

Version/Model Number

5.14

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K051745

Product Code Details

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Device Record Status

Public Device Record Key

86b47a4f-bc72-4397-8c5c-108ea673955f

Public Version Date

August 11, 2020

Public Version Number

1

DI Record Publish Date

August 03, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDSTRAT, 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