Manufacturer
Spectrum Dynamics Medical
Israel, SwitzerlandLegal entities : Spectrum Dynamics Medical SA, Spectrum Dynamics Medical ltd
Markets : Austria · Belgium · France · Germany · Poland · Spain · Sweden · United States
Approvals : EU – class IIa, IIb · United States (FDA) – 510(k) : 8 · class II · latest in 2026 · see on the FDA website
Public contracts won : Belgium 2 · France 1 · Sweden 1
EU representative : SPECTRUM DYNAMICS MEDICAL FRANCE SAS (France)
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a category to see competitors, a model to open its EUDAMED record.
| Category | EMDN code | Registered models | Class | Contact |
|---|---|---|---|---|
| CT/gamma camera systems | Z11020201 |
|
IIb MDR | EUDAMED record Report an error |
| Fixed station gamma cameras with multiple heads - without ‘total body’ acquisition | Z11020104 | IIa MDR | EUDAMED record Report an error | |
| Various instruments for nuclear medicine - software accessories | Z11029082 | IIb MDR | EUDAMED record Report an error | |
| Fixed station gamma cameras with multiple heads - with ‘total body’ acquisition No model still on the market | Z11020105 |
|
IIa MDR | EUDAMED record Report an error |
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