Identity
- Trade Name
- Standard Imaging StructSure Software FDA UDI
- Generic Name
- Accelerator system quality assurance device FDA UDI
- Device Name
- Standard Imaging StructSure Software is designed to be used to assess the anatomical capabilities of: 1) clinical professionals who are responsible for contouring organs-at-risk and target volumes, i.e. manual contouring; and 2) automated contouring software systems, i.e. auto-segmentation. FDA UDI
- Model / Reference
- 91340 FDA UDI
- Description
- Standard Imaging StructSure Software is designed to be used to assess the anatomical capabilities of: 1) clinical professionals who are responsible for contouring organs-at-risk and target volumes, i.e. manual contouring; and 2) automated contouring software systems, i.e. auto-segmentation. FDA UDI
Identifiers
- Catalog Number
- 91340 FDA UDI
- Primary DI / UDI-DI
- 00866562000281 FDA UDI
- FDA Product Code
- LHO FDA UDI
- GMDN Term
- Accelerator system quality assurance device FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1940 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Accelerator system quality assurance device
Standard Imaging StructSure Software by Standard Imaging, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Standard Imaging, Inc.
Sources (1)
- FDA UDI 871c9969-1063-4adb-8854-8657d6010828 34 fields · synced Jun 8, 2026