Joints
- Primary DI
- 00817886020578
- Brand
- Joints
- Company
- MEDSTRAT, INC.
- Model
- 6.2
- 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
- 2024-04-12
- 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
| Code | Name |
|---|---|
| LLZ | System, Image Processing, Radiological |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 2 |
Premarket Submissions
| Submission | Supplement |
|---|---|
| K051745 | 000 |
Premarket Details
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00817886020578 | Primary | GS1 | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| Radiological PACS software | An 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. |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| 800-882-4224 | support@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
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00817886020677 | Joints | 6.12 | 2026-02-16 | |
| 00817886020660 | Joints | 6.11 | 2025-08-09 | |
| 00817886020653 | Joints | 6.10 | 2025-06-27 | |
| 00817886020646 | Joints | 6.9 | 2025-04-30 | |
| 00817886020639 | Joints | 6.8 | 2025-03-07 | |
| 00817886020622 | Joints | 6.7 | 2025-02-03 | |
| 00817886020615 | Joints | 6.6 | 2024-12-09 | |
| 00817886020608 | Joints | 6.5 | 2024-11-01 | |
| 00817886020592 | Joints | 6.4 | 2024-08-31 | |
| 00817886020585 | Joints | 6.3 | 2024-06-08 | |
| 00817886020561 | Joints | 6.1 | 2024-02-10 | |
| 00817886020554 | Joints | 6.0 | 2023-11-13 | |
| 00817886020295 | Joints | 5.16 | 2020-10-05 | |
| 00817886020486 | Joints | 5.35 | 2023-01-20 | |
| 00817886020516 | Joints | 5.38 | 2023-05-29 | |
| 00817886020509 | Joints | 5.37 | 2023-04-03 | |
| 00817886020493 | Joints | 5.36 | 2023-03-06 | |
| 00817886020479 | Joints | 5.34 | 2022-10-29 | |
| 00817886020462 | Joints | 5.33 | 2022-09-05 | |
| 00817886020455 | Joints | 5.32 | 2022-08-01 |
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