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Spectral Color Overlay
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 5929649Model Spectral Color Overlay
Identity
- Trade Name
- Spectral Color Overlay EUDAMEDFDA UDI
- Generic Name
- CT system application software FDA UDI
- Device Name
- Spectral Color Overlay EUDAMEDSpectral Color Overlay MD Application Container for Smart Subscription FDA UDI
- Model / Reference
- Spectral Color Overlay EUDAMED5929649 EUDAMED1.0 FDA UDI
- Description
- Spectral Color Overlay MD Application Container for Smart Subscription FDA UDI
Identifiers
- Catalog Number
- 5929649 FDA UDI
- Primary DI / UDI-DI
- 00195278630384 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00413H9 EUDAMED
- Direct Marketing DI
- 00195278630384 EUDAMED
- FDA Product Code
- JAK FDA UDI
- EMDN Code
- Z11030692 COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- CT system application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1750 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- France 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
Spectral Color Overlay by GE Medical Systems, LLC — Class IIa — 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 | 8406821BUG00413H9 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- GE Medical Systems, LLC
- EUDAMED SRN
- US-MF-000018315
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (2)
- EUDAMED 7d762517-825d-4312-84e1-e6e1cdf97806 61 fields · synced Jul 9, 2026
- FDA UDI 0022bab6-2fe4-4ed6-bbee-dfffaaabf3d1 34 fields · synced May 29, 2026