Philips CT 3500
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Philips CT 3500 EUDAMED
- Device Name
- CT Scanner System (Philips CT 3500) EUDAMED
- Model / Reference
- 728134 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00884838111318 EUDAMED
- Basic UDI-DI
- 0884838BM1060LT EUDAMED
- Direct Marketing DI
- 00884838111318 EUDAMED
- 510(k) Number
- K223311 FDA 510(k)
- FDA Product Code
- JAK FDA 510(k)
- EMDN Code
- Z11030605 COMPUTED TOMOGRAPHS - 64 LAYERS OR MORE BUT LESS THAN 128 LAYERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1750 FDA 510(k)
- Regulation Number
- 892.1750 FDA 510(k)
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Philips CT 3500 is a computed tomography (CT) scanner designed for high-resolution imaging of the body. It provides detailed cross-sectional images of internal structures, enabling precise diagnosis and evaluation of anatomical and pathological conditions in radiology settings.
This device is intended for use in clinical environments where advanced imaging is required, supplied as a reusable medical system. It complies with FDA 510(k) clearance under the Radiology Advisory Committee and is authorized under the Medical Device Regulation (MDR). The system is intended for professional healthcare settings and requires appropriate training for operation.
Frequently asked questions
What types of medical environments is the Philips CT 3500 intended for, and what level of expertise is required to operate it?
The Philips CT 3500 is designed for professional healthcare settings where advanced imaging is essential, such as hospitals, specialized radiology clinics, or research institutions. Due to its complexity as a computed tomography scanner, operation requires trained radiologic technologists or medical physicists with formal training in CT imaging techniques. The device is not intended for point-of-care or non-clinical use.
Is the Philips CT 3500 a single-use or reusable device, and how does this affect maintenance?
The Philips CT 3500 is explicitly described as a reusable medical system, meaning it is built for repeated use in clinical settings. As a reusable device, it requires a structured maintenance program—including regular servicing, calibration, and cleaning—to ensure consistent performance, safety, and compliance with regulatory standards like FDA 510(k) requirements.
What regulatory pathways does the Philips CT 3500 follow, and how does this impact its use in different markets?
The Philips CT 3500 has undergone FDA 510(k) clearance under the Radiology Advisory Committee (RA) and is authorized under the Medical Device Regulation (MDR). This means it meets U.S. and EU regulatory standards for high-risk imaging devices, ensuring its use is compliant with local health authority requirements in those markets. However, buyers should verify additional local regulations, as approvals may vary by country.
How does the high-resolution imaging capability of the Philips CT 3500 benefit clinical diagnostics?
The Philips CT 3500 is engineered for high-resolution imaging, allowing it to capture detailed cross-sectional views of internal structures with precision. This capability enables clinicians to better diagnose and evaluate complex anatomical and pathological conditions—such as tumors, vascular issues, or skeletal abnormalities—by reducing ambiguity in image interpretation and improving early detection of abnormalities.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K223311 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Healthcare (Suzhou) Co., Ltd.
Sources (2)
- FDA 510(k) K223311 24 fields · synced Sep 18, 2026
- EUDAMED c3f3baa1-effa-4859-95e6-478adb7fa806 61 fields · synced Jul 9, 2026