Identity
- Trade Name
- Brilliance iCT System Upgrade EUDAMEDFDA UDI
- Generic Name
- Full-body CT system FDA UDI
- Device Name
- BRILLIANCE iCT SYSTEM EUDAMED
- Model / Reference
- 728305 EUDAMEDBrilliance iCT system Upgrade FDA UDI
Identifiers
- Catalog Number
- 728305 FDA UDI
- Primary DI / UDI-DI
- 00884838098718 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM278T9 EUDAMED
- FDA Product Code
- JAK FDA UDI
- EMDN Code
- Z11030682 COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES 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
- 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
Yes
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
Category: Full-body CT system
Brilliance iCT System Upgrade by Philips Medical Systems Nederland B.V. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Full-body CT system.
- NAEOTOM Alpha.Prime — Siemens Healthcare · Class II
- SpotLight — Arineta , Ltd. · Class II
- TruPlan — Circle Cardiovascular Imaging Inc · Class IIa
- Osteo mat — Siemens Healthcare · Class II
- TOSHIBA SCANNER — Canon Medical Systems Corporation · Class II
- Bariatric table top — Siemens Healthcare · Class II
- Optima — Hangwei GE Medical Systems Co., Ltd. · Class II
- table extension_P68 — Siemens Shanghai Medical Equipment Ltd. · Class II
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 | 0884838BM278T9 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Philips Medical Systems Nederland B.V.
- EUDAMED SRN
- NL-MF-000001489
Sources (2)
- EUDAMED d605f377-cfce-4453-adc0-060b76722a61 61 fields · synced Sep 18, 2026
- FDA UDI 7e008189-e185-4fed-bf4a-c1f0a682d8bf 33 fields · synced May 30, 2026