FDA UDI
In Commercial Distribution
🇺🇸 United States
Simpleware ScanIP Medical
DI: 00863520000390
·
Model: S-2021.06 onwards
·
SYNOPSYS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Simpleware ScanIP Medical
- Primary DI
- 00863520000390
- Version / Model
- S-2021.06 onwards
- Company Name
- SYNOPSYS, INC.
- Labeler DUNS
- 161499579
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-07
- Public Version
- 5
- Public Version Date
- 2023-11-30
- Public Version Status
- Update
- Public Device Record Key
- 24b62db0-aee3-4b32-b3cf-b347e360b29f
Device Description
Current software release: T-2022.03. Next software release: V-2024.03 Simpleware ScanIP Medical is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. It is also intended as pre-operative software for diagnostic and surgical planning. For these purposes, output files can also be used for the fabrication of physical replicas using traditional or additive manufacturing methods. The physical replicas can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications. The software is intended to be used in conjunction with other diagnostic tools and expert clinical judgment.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41670 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00863520000390 | GS1 |
Customer Contacts
- Phone
- +4401392428750
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K203195 | 000 |