Identity
- Trade Name
- DTX Studio™ diagnose FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- DTX Studio diagnose 1.3 for Windows 64-bit FDA UDI
- Model / Reference
- 1.3 FDA UDI
- Description
- DTX Studio diagnose 1.3 for Windows 64-bit FDA UDI
Identifiers
- Catalog Number
- 300123 FDA UDI
- Primary DI / UDI-DI
- 07332747152166 FDA UDI
- 510(k) Number
- FDA Product Code
- LLZ FDA 510(k)FDA UDI
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)FDA UDI
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- Not 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
DTX Studio diagnose by Nobel Biocare AB — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172224 | Class II | Active |
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Manufacturer
- Manufacturer
- Nobel Biocare AB
Sources (2)
- FDA 510(k) K172224 24 fields · synced Jun 18, 2026
- FDA UDI 0042c304-0934-49d7-9807-dbf0029da9af 37 fields · synced May 22, 2026