Identity
- Trade Name
- fullAccess FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- A fully-integrated data display, communication and analysis software platform that enables users to access, analyze and share diagnostic images and radiotherapy treatment plans. FDA UDI
- Model / Reference
- 1.x FDA UDI
- Description
- A fully-integrated data display, communication and analysis software platform that enables users to access, analyze and share diagnostic images and radiotherapy treatment plans. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00863284000308 FDA UDI
- 510(k) Number
- K101707 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiology DICOM image processing application software
fullAccess by Radialogica Llc — 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
- Radialogica Llc
Sources (1)
- FDA UDI f4ff80fc-9d29-440e-9d0d-7ae4f1b92f24 35 fields · synced May 30, 2026