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DTX Studio Clinic 4.3 for Mac
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 300851_V4.3_MAC
Identity
- Trade Name
- DTX Studio Clinic 4.3 for Mac EUDAMEDDTX Studio™ Clinic FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- Diagnostic and treatment software EUDAMEDDTX Studio Clinic 4.3 for Mac FDA UDI
- Model / Reference
- 300851_V4.3_MAC EUDAMED4.3 FDA UDI
- Description
- DTX Studio Clinic 4.3 for Mac FDA UDI
Identifiers
- Catalog Number
- 300851 FDA UDI
- Primary DI / UDI-DI
- 07332747215229 EUDAMEDFDA UDI
- Basic UDI-DI
- 73327470000002206S EUDAMED
- 510(k) Number
- K231898 FDA UDI
- FDA Product Code
- LLZ FDA UDIMYN FDA UDI
- EMDN Code
- Z11069082 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI892.2070 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
DTX Studio Clinic 4.3 for Mac by Nobel Biocare AB — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 73327470000002206S | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Nobel Biocare AB
- EUDAMED SRN
- SE-MF-000000009
Sources (2)
- EUDAMED 9d46c7e9-c02a-4a13-95fd-25e9fb209b6e 61 fields · synced Jun 18, 2026
- FDA UDI b63ced37-6980-4079-a7fd-630eb4c55df0 36 fields · synced May 30, 2026