Joints

Primary DI
00817886020509
Brand
Joints
Company
MEDSTRAT, INC.
Model
5.37
Device description
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.
Published
2023-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications

CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions

SubmissionSupplement
K051745000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K051745000ECHOSYSTEMMedstrat, Inc.2005-07-14LLZ

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817886020509PrimaryGS10

GMDN Terms

TermDefinition
Radiology PACS softwareAn individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images. It is designed specifically for use within radiology.

Sterilization Methods

Method

Contacts

PhoneEmail
800-882-4224support@medstrat.com

Regulatory Flags

DUNS number
152206371
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00817886020561Joints6.12024-02-10
00817886020554Joints6.02023-11-13
00817886020295Joints5.162020-10-05
00817886020486Joints5.352023-01-20
00817886020516Joints5.382023-05-29
00817886020493Joints5.362023-03-06
00817886020479Joints5.342022-10-29
00817886020462Joints5.332022-09-05
00817886020455Joints5.322022-08-01

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