← Back to catalogue
QuantumCam
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 9SYS2070-C05510(k) K161674
Identity
- Trade Name
- QuantumCam FDA UDI
- Generic Name
- Stationary gamma camera system FDA UDI
- Device Name
- QuantumCam EUDAMEDGamma Camera System FDA UDI
- Model / Reference
- 9SYS2070-C05 EUDAMEDQuantumCam Gamma Camera System FDA UDI
- Description
- Gamma Camera System FDA UDI
Identifiers
- Catalog Number
- 9SYS2070 FDA UDI
- Primary DI / UDI-DI
- 05711665003033 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05711665003033 EUDAMED
- 510(k) Number
- K161674 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
- Stationary gamma camera system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1200 FDA UDI
- Market of Registration
- Denmark 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Dimensions & Sizes
- Size
- Weight — 2144 Kilogram FDA UDIHeight — 225 Centimeter FDA UDIDepth — 197 Centimeter FDA UDIWidth — 291 Centimeter FDA UDI
QuantumCam by Ddd-Diagnostic A/S — Class IIa — FDA_510K, MDD — 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161674 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-05711665003033 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DDD-Diagnostic A/S
- EUDAMED SRN
- DK-MF-000009162
Sources (3)
- EUDAMED b2341192-c591-4135-88dc-0f0e3eff551b 85 fields · synced Jun 19, 2026
- FDA UDI d2982603-1a56-426c-96b7-299b564a631d 37 fields · synced May 29, 2026
- FDA 510(k) K161674 1 fields · synced May 18, 2026