Identity
- Trade Name
- PROcedure Rehearsal Studio FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- Image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner to an output file. It is also intended as pre-operative software for surgical planning. FDA UDI
- Model / Reference
- 2.0.1. FDA UDI
- Description
- Image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner to an output file. It is also intended as pre-operative software for surgical planning. FDA UDI
Identifiers
- Catalog Number
- PROcedure Rehearsal Studio FDA UDI
- Primary DI / UDI-DI
- 00816847021371 FDA UDI
- 510(k) Number
- K153705 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Radiology DICOM image processing 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiology DICOM image processing application software
PROcedure Rehearsal Studio by 3d Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 77bf4113-8648-4da3-b316-89e0f9af50f7 36 fields · synced Jun 1, 2026