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HealthCCSng
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref HealthCCSng 2.1Model 2.1
Identity
- Trade Name
- HealthCCSng EUDAMEDFDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- HealthCCSng EUDAMED- FDA UDI
- Model / Reference
- 2.1 EUDAMEDFDA UDIHealthCCSng 2.1 EUDAMED
- Description
- - FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290018016176 EUDAMEDFDA UDI
- Basic UDI-DI
- 7290018016HealthCCSng21NC EUDAMED
- 510(k) Number
- K241440 FDA UDI
- FDA Product Code
- JAK FDA UDI
- EMDN Code
- Z11030692 COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1750 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Netherlands 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
HealthCCSng by Nano-X AI Ltd. — Class IIb — 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 | K241440 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 7290018016HealthCCSng21NC | Class IIb | Active |
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Manufacturer
- Manufacturer
- Nano-X AI Ltd.
- EUDAMED SRN
- IL-MF-000010234
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (3)
- EUDAMED fbdd6a8a-e4f8-45ca-acbf-c06d167bd448 61 fields · synced Jul 30, 2026
- FDA UDI 746ae767-95e0-4ed2-a2fa-9c0d835b9e56 34 fields · synced May 27, 2026
- FDA 510(k) K241440 1 fields · synced May 18, 2026