Identity
- Trade Name
- D2P FDA UDI
- Generic Name
- Image segmentation application software FDA UDI
- Device Name
- The D2P software is a stand-alone modular software package that provides advanced visualization of DICOM imaging data. This modular package includes, but is not limited to the following functions: - DICOM viewer and analysis - Automated segmentation - Editing and pre-printing - Seamless integration with 3D Systems printers - Seamless integration with 3D Systems software packages - Seamless integration with Virtual Reality visualization for non-diagnostic use FDA UDI
- Model / Reference
- 1.0.3 FDA UDI
- Description
- The D2P software is a stand-alone modular software package that provides advanced visualization of DICOM imaging data. This modular package includes, but is not limited to the following functions: - DICOM viewer and analysis - Automated segmentation - Editing and pre-printing - Seamless integration with 3D Systems printers - Seamless integration with 3D Systems software packages - Seamless integration with Virtual Reality visualization for non-diagnostic use FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816847022569 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Image segmentation application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Image segmentation application software
D2p by 3d Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K161841 also covers:
K183489 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- 3d Systems, Inc.
Sources (1)
- FDA UDI 9bd4a89d-7f00-4e93-9865-e23a13127fff 34 fields · synced Jun 8, 2026