Identity
- Trade Name
- EXINI Bone EUDAMEDFDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- EXINI bone EUDAMEDEXINI bone is a stand alone software intended for Windows OS platform. Users of the device can import whole body bone scintigraphy image data, view it using 2D medical image viewers, view and export quantitative analysis values. FDA UDI
- Model / Reference
- 303 EUDAMED03 FDA UDI
- Description
- EXINI bone is a stand alone software intended for Windows OS platform. Users of the device can import whole body bone scintigraphy image data, view it using 2D medical image viewers, view and export quantitative analysis values. FDA UDI
Identifiers
- Catalog Number
- 303 FDA UDI
- Primary DI / UDI-DI
- 07350002333037 EUDAMEDFDA UDI
- Basic UDI-DI
- 73500023333G EUDAMED
- 510(k) Number
- K191262 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 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
No
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
No
FDA UDI
EXINI Bone by Exini Diagnostics Ab — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K122205 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 73500023333G | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- EXINI Diagnostics AB
- EUDAMED SRN
- SE-MF-000001840
Sources (3)
- EUDAMED 1ee3299b-3e64-417b-8b6d-7e3689d46a6d 61 fields · synced Jun 18, 2026
- FDA UDI 336a326a-a467-4fe4-b74f-29479e0e78da 36 fields · synced May 30, 2026
- FDA 510(k) K122205 1 fields · synced May 18, 2026