Identity
- Trade Name
- Incisive CT EUDAMEDFDA UDI
- Generic Name
- Full-body CT system FDA UDI
- Device Name
- CT Scanner System (Incisive CT/CT5300) EUDAMED
- Model / Reference
- 728143 EUDAMEDIncisive CT FDA UDI
Identifiers
- Catalog Number
- 728143 FDA UDI
- Primary DI / UDI-DI
- 00884838085015 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM285T6 EUDAMED
- Direct Marketing DI
- 00884838085015 EUDAMED
- FDA Product Code
- JAK FDA UDI
- EMDN Code
- Z11030606 COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS EUDAMED
- GMDN Term
- Full-body CT system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1750 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- Not 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
No
FDA UDI
Incisive CT by Philips Healthcare (Suzhou) Co., 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
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 | K180015 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K212441 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 0884838BM285T6 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Philips Healthcare (Suzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000003923
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (3)
- EUDAMED 506cc0e6-c8a6-41f3-8f3a-3612e32a334b 61 fields · synced Jul 16, 2026
- FDA UDI 1132d7f7-9bf0-4915-a93c-147f8b8a7bb6 34 fields · synced May 30, 2026
- FDA 510(k) K180015 1 fields · synced May 18, 2026