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.
Catalog Number
-
Brand Name
Joints
Version/Model Number
5.8
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
1e981f47-2dc0-4fae-9e79-36e500bec2f7
Public Version Date
October 08, 2019
Public Version Number
1
DI Record Publish Date
September 30, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 44 |