Sentinel 4DCT
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Identity
- Trade Name
- Sentinel 4DCT EUDAMEDSentinel FDA UDI
- Generic Name
- Laser patient positioning system FDA UDI
- Device Name
- Sentinel 4DCT EUDAMED
- Model / Reference
- SP001-0022 EUDAMEDSP001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350005280017 EUDAMEDFDA UDI
- Basic UDI-DI
- 735000528SentinelG9 EUDAMEDB-07350005280017 EUDAMED
- Direct Marketing DI
- 07350005280017 EUDAMED
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z119010 LASER SYSTEMS FOR PATIENT POSITIONING EUDAMED
- GMDN Term
- Laser patient positioning system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
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
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Laser patient positioning system
The Sentinel 4DCT is a Cone Beam Computed Tomography (CBCT) system for real-time imaging and tracking during radiation therapy, classified under nomenclature code Z119010. It integrates imaging and positioning capabilities to enhance precision in delivering targeted radiation doses, supporting adaptive treatment planning and verification.
This device is non-sterile, non-reusable, and non-implantable, supplied as an active medical system with a unique UDI (735000528SentinelG9). It operates in radiation oncology settings, requiring compliance with MRI safety guidelines for the specific environment. Authorised under FDA 510(k) clearance, MDD, and MDR, it is intended for use in facilities equipped for advanced imaging and therapy, with no latex components or animal-derived substances.
Similar devices
Also classified as Laser patient positioning system.
- Sun Nuclear MICRO — Sun Nuclear Corporation · Class I
- DORADO — L A P GMBH LASER APPLIKATIONEN · Class I
- DORADO — L A P GMBH LASER APPLIKATIONEN · Class I
- Laser Positioning System — Klarity Medical & Equipment（GZ） Co.,Ltd. · Class I
- DORADO — L A P GMBH LASER APPLIKATIONEN · Class I
- HIT Laser — C-Rad Positioning AB · Class I
- APOLLO MR3T blue line 90° — LAP GmbH Laser Applikationen · Class I
- Sun Nuclear MICRO — Sun Nuclear Corporation · Class I
Frequently asked questions
What types of radiation therapy settings is the Sentinel 4DCT designed for, and how does it enhance precision in treatment?
The Sentinel 4DCT is designed for radiation oncology facilities that require advanced imaging and adaptive treatment planning. It integrates Cone Beam Computed Tomography (CBCT) with real-time imaging and positioning capabilities, enabling precise tracking of patient movement and anatomical changes during therapy. This integration helps deliver targeted radiation doses more accurately, supporting adaptive treatment planning and verification to improve treatment outcomes.
Is the Sentinel 4DCT reusable, and if not, what does this mean for its maintenance and replacement cycle?
No, the Sentinel 4DCT is non-reusable, meaning it is intended for single-use only. This design eliminates the need for reprocessing or sterilization between uses, simplifying maintenance protocols. However, it does require replacement after each procedure, which should be accounted for in inventory and procurement planning to ensure continuous availability for patients.
Does the Sentinel 4DCT contain any materials that could pose risks to patients with allergies or sensitivities, and what safety guidelines should be followed?
The Sentinel 4DCT is explicitly stated to have no latex components or animal-derived substances, making it suitable for patients with latex allergies or sensitivities to animal-derived materials. However, since it operates in a radiation oncology setting, facilities must also comply with MRI safety guidelines for the specific environment where the device is used to ensure patient and staff safety.
How is the Sentinel 4DCT identified for regulatory and inventory purposes, and what does its UDI number represent?
The Sentinel 4DCT is identified by its unique UDI (Unique Device Identifier) number: 735000528SentinelG9, which includes a Basic UDI (735000528SentinelG9) and associated UDI data (e.g., 01HP72EC3AC3EDX19ZCHERF8C7). This UDI ensures traceability for regulatory compliance, inventory management, and recall purposes, allowing healthcare providers to accurately track and manage the device throughout its lifecycle.
What should clinicians consider when storing or handling the Sentinel 4DCT, given its non-sterile and single-use nature?
Since the Sentinel 4DCT is non-sterile and non-reusable, clinicians should store it in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its functionality. As it is intended for single-use, it should be handled with care to avoid contamination before use, and any unused components should be discarded according to facility protocols for non-sterile medical devices.
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
CE/MDD
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 735000528SentinelG9 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K200600 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K120668 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 735000528SentinelG9 | Class IIb | Active |
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Manufacturer
- Manufacturer
- C-RAD Positioning AB
- EUDAMED SRN
- SE-MF-000022326
Sources (4)
- EUDAMED fa44bac3-7ad9-4022-b908-bdf7c71b9efb 85 fields · synced Sep 18, 2026
- EUDAMED 9cddc91d-6f30-46c3-88a6-d6ff5fb231fa 61 fields · synced May 19, 2026
- FDA UDI ca8ff51e-7367-401b-b703-933fa9ed05bc 34 fields · synced May 29, 2026
- FDA 510(k) K200600 1 fields · synced May 18, 2026