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Veriton Nm 300
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 8010426-01Model VERITON NM
Identity
- Trade Name
- VERITON NM 300 EUDAMEDVERITON NM FDA UDI
- Generic Name
- SPECT system, annular detector array FDA UDI
- Device Name
- VERITON NM SPECT system EUDAMEDSingle Photon Emission Computed Tomography System WITH ‘TOTAL BODY’ ACQUISITION FDA UDI
- Model / Reference
- VERITON NM EUDAMED8010426-01 EUDAMED300 FDA UDI
- Description
- Single Photon Emission Computed Tomography System WITH ‘TOTAL BODY’ ACQUISITION FDA UDI
Identifiers
- Catalog Number
- 8010426-01 FDA UDI
- Primary DI / UDI-DI
- 07290108670202 EUDAMEDFDA UDI
- Basic UDI-DI
- 729010867VERITONXF EUDAMED
- Direct Marketing DI
- 07290108670202 EUDAMED
- 510(k) Number
- K230600 FDA UDI
- FDA Product Code
- KPS FDA UDI
- EMDN Code
- Z11020105 FIXED STATION GAMMA CAMERAS WITH MULTIPLE HEADS - WITH ‘TOTAL BODY’ ACQUISITION EUDAMED
- GMDN Term
- SPECT system, annular detector array FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1200 FDA UDI
- Market of Registration
- Poland 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Veriton Nm 300 by Spectrum Dynamics Medical ltd — 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 | K180514 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 729010867VERITONXF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Spectrum Dynamics Medical ltd
- EUDAMED SRN
- IL-MF-000013887
- Authorised Representative
- SPECTRUM DYNAMICS MEDICAL FRANCE SAS FR-AR-000013226
Sources (3)
- EUDAMED abddcad1-f616-46ec-9d90-b332bb00b25a 61 fields · synced Jun 19, 2026
- FDA UDI dd88ded5-6281-4513-a279-472cf6bcbee5 35 fields · synced May 30, 2026
- FDA 510(k) K180514 1 fields · synced May 18, 2026